Atlas FDA

GAS MODULE II, MODEL 0998-00-0143

FDA 510(k) clearance K974903 · decided 1998-03-13

Clearance details

K-number
K974903
Device name
GAS MODULE II, MODEL 0998-00-0143
Applicant
Datascope Corp.
Decision
Substantially Equivalent
Date received
1997-12-31
Decision date
1998-03-13
Days to decision
72 days
Clearance type
Traditional
Product code
CBS
Device class
2
Regulation number
868.1620
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
VITALMAX 4100 (K953795)Pace Tech, Inc.1996-07-01
AS/3 COMPACT AIRWAY MODULE M-CAIOV (K960490)Datex Medical Instrumentation, Inc.1996-05-03
RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) (K951366)Riken Keiki Co., Ltd.1995-08-02
RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR (K950101)Marquette Electronics, Inc.1995-03-21
AS/3 AIRWAY MODULE (K943458)Datex Division Instrumentarium Corp.1995-02-14
POET IQ WITH FIVE AGENT CAPABILITY (K942737)Criticare Systems, Inc.1995-02-09
8100 ANESTHETIC AGENT MONITOR (K932389)Biochem International, Inc.1993-12-03
CAPNOMAC ULTIMA ANESTHESIA MONITOR (K905754)Datex Division Instrumentarium Corp.1991-06-17
NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR (K896629)Nellcor, Inc.1990-02-12
HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A (K896216)Hewlett-Packard Co.1990-01-16
ANESTHETIC GAS MONITOR (K890446)Bruel & Kjaer Instruments, Inc.1989-08-11
SPECTRAMED RESPIRATORY GAS ANALYZER (K873194)Draeger Medical, Inc.1987-10-30

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