Atlas FDA

MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS

FDA 510(k) clearance K961223 · decided 1996-12-10

Clearance details

K-number
K961223
Device name
MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS
Applicant
Criticare Systems, Inc.
Decision
Substantially Equivalent
Date received
1996-03-29
Decision date
1996-12-10
Days to decision
256 days
Clearance type
Traditional
Product code
LOS
Advisory committee
Unknown
Location
Waukesha, WI, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
EKG-PLUS II SOFTWARE (K090895)Bionet Co., Ltd.2009-08-26
CARDIOVIEW32 REVIEW MODULE (K083749)Qrs Diagnostic, LLC2009-03-10
PHILIPS ECG ALGORITHM (K073376)Philips Medical Systems2008-04-11
CARDIOTOUCH-3000 (K023034)Bionet Company, Ltd.2002-11-14
CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH (K011328)Bionet Company, Ltd.2001-11-21
CARDIO-CARD INTERPRETATION SYSTEM I (K993616)Nasiff Assoc., Inc.2000-04-10
OXYCONALPHA WITH OPTION ECG (K984465)Erich Jaeger B.V.1999-10-27
CASE 8000 EXERCISE TESTING SYSTEM (K991014)General Electric Medical Systems Information Techn1999-10-20
MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS (K991735)General Electric Medical Systems Information Techn1999-08-19
NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES (K990031)Nihon Kohden America, Inc.1999-04-16
NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES (K984504)Nihon Kohden America, Inc.1999-04-15
MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE (K990266)Micromedical Industries, Ltd.1999-02-02

Recalls involving this device

No recalls on record reference this clearance.