Atlas FDA

DATASCOPE MULTINEX ID PLUS

FDA 510(k) clearance K930303 · decided 1993-06-16

Clearance details

K-number
K930303
Device name
DATASCOPE MULTINEX ID PLUS
Applicant
Datascope Corp.
Decision
Substantially Equivalent
Date received
1993-01-21
Decision date
1993-06-16
Days to decision
146 days
Clearance type
Traditional
Product code
CBQ
Device class
2
Regulation number
868.1500
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Paramus, NJ, 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
PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B (K040917)Philips Medizin Systeme Boeblingen GmbH2004-04-29
MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 (K994188)Agilent Technologies, GmbH2000-05-19
OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR (K962648)Ohmeda Medical1997-01-17
OHMEDA MODEL 5330 ANESTHETIC MONITOR (K931439)Ohmeda Medical1993-10-19
DATASCOPE MULTINEX II (K926451)Datascope Corp.1993-08-25
AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE (K923433)Instrumentarium Corp.1993-07-22
CAPNOMAC ULTIMA ANESTHESIA MONITOR (K923276)Datex Division Instrumentarium Corp.1993-07-21
AS/3 COP MODULE (K922876)Datex Division Instrumentarium Corp.1993-07-21
ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED (K914295)Bruel & Kjaer1992-04-10
NGM FRAME (K911644)Datex Division Instrumentarium Corp.1992-03-04
NGM GAS MODULE (K911647)Datex Division Instrumentarium Corp.1991-09-19
CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR (K903104)Datex Division Instrumentarium Corp.1991-01-23

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ABSORBABLE COLLAGEN HEMOSTAT (P850023/S014)Datascope Corp.1994-12-22
HEMOPAD(TM) ABSORBABLE COLLAGEN HEMOSTAT (P850023/S010)Datascope Corp.1992-11-16
ABSORBABLE COLLAGEN HEMOSTAT (P850023/S013)Datascope Corp.1992-08-26
HEMAFLEX (TM) MED-CHEM PRODUCTS,DISTRIBUTOR (P850023/S011)Datascope Corp.1991-10-04
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S009)Datascope Corp.1990-09-28
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S005)Datascope Corp.1989-05-17
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S008)Datascope Corp.1989-03-09
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S006)Datascope Corp.1988-09-09