Atlas FDA

NGM FRAME

FDA 510(k) clearance K911644 · decided 1992-03-04

Clearance details

K-number
K911644
Device name
NGM FRAME
Applicant
Datex Division Instrumentarium Corp.
Decision
Substantially Equivalent
Date received
1991-04-15
Decision date
1992-03-04
Days to decision
324 days
Clearance type
Traditional
Product code
CBQ
Device class
2
Regulation number
868.1500
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Tewksbury, MA, 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
DATASCOPE MULTINEX ID PLUS (K930303)Datascope Corp.1993-06-16
ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED (K914295)Bruel & Kjaer1992-04-10
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.