Atlas FDA

HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A

FDA 510(k) clearance K992636 · decided 1999-08-31

Clearance details

K-number
K992636
Device name
HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
Applicant
Hewlett-Packard Co.
Decision
Substantially Equivalent
Date received
1999-08-06
Decision date
1999-08-31
Days to decision
25 days
Clearance type
Special
Product code
DXJ
Device class
2
Regulation number
870.2450
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Andover, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Hewlett-Packard Co.

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ESSENZ Patient Monitor (K212003)Livanova Deutschland, GmbH2021-11-10
Philips IntelliVue GuardianSoftware (Rev. E.0X) (K212208)Philips Medizin Systeme Boeblingen GmbH2021-09-30
Essence 55SP Large Monitor System (K201162)Shenyang Torch-Bigtide Digital Technology Co., Ltd.2020-08-27
Vios Central Station Monitor Software, Vios Central Server Software (K173107)Vios Medical, Inc.2018-07-26
Philips IntelliVue GuardianSoftware (K180534)Philips Medizin Systeme Boeblingen GmbH2018-07-16
Nexxis OR (K173381)Barco N.V.2018-02-22
Essence 55S Large Monitor System (K172969)Shenyang Torch-Bigtide Digital Technology Co., Ltd.2018-01-26
Sorin Connect (K170460)Sorin Group Deutschland GmbH2017-06-08
Nexxis OR, Nexxis (K170537)Barco N.V.2017-04-21
NIVR58-T kit (K161880)Barco N.V.2017-03-14
Philips IntelliVue GuardianSoftware (K161767)Philips Medizin Systeme Boeblingen GmbH2017-01-27
CARESCAPE Central Station V2 (K162012)GE Healthcare2016-09-15

Recalls involving this device

RecordFirmDate
Philips Medical: 865047 IntelliVue Clinical Information Portfolio Release D.03 865209 Inte recall (Z-3111-2011)Philips Healthcare Inc.2011-08-31
Philips IntelliVue Clinical Information Portfolio software as follows: 865047 IntelliVue C recall (Z-2175-2011)Philips Healthcare Inc.2011-05-10
Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Softw recall (Z-0414-2011)Philips Healthcare Inc.2010-11-18
IntelliVue Clinical Information Portfolio (ICIP) Critical Care Release D, Version D.02. In recall (Z-0418-2010)Philips Healthcare Inc.2009-11-24
Philips IntelliVue Clinical Information Portfolio Software Version D.0, for patient data c recall (Z-1654-2009)Philips Healthcare Inc.2009-07-07
CareVue Chart Release C.O Part Number: 862246 Intended for use in data collection, storage recall (Z-1436-2009)Philips Healthcare Inc.2009-05-27
CareVue Chart Release C ,Versions C.00.00 through C.00.06 Product No. 862246. This device recall (Z-1540-2008)Philips Medical Systems2008-08-23
IntelliVue Clinical Information Portfolio Critical Care Release D, Version D.00.00 Product recall (Z-1541-2008)Philips Medical Systems2008-08-23