FDA.report

510(k) K881264

Device
PERMA PURE NAFION TUBE DRYER-MODEL ME
Applicant
PERMA PURE PRODUCTS, INC.
510(k) number
K881264
Product code
CBQ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-10-25
Date received
1988-03-24
Regulation
868.1500
Classification name
Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Related Records

Applicant Contact

Contact
KERTZMAN
Address
8 Executive Dr. P.O. Box 2105 Toms River NJ US 08753 08753

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CBQ  

510(k)DeviceApplicantDecision date
K040917PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026BPhilips Medizin Systeme Boeblingen GmbH2004-04-29
K994188MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5Agilent Technologies, GmbH2000-05-19
K962648OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOROhmeda Medical1997-01-17
K931439OHMEDA MODEL 5330 ANESTHETIC MONITOROhmeda Medical1993-10-19
K926451DATASCOPE MULTINEX IIDatascope Corp.1993-08-25
K923433AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULEInstrumentarium Corp.1993-07-22
K923276CAPNOMAC ULTIMA ANESTHESIA MONITORDatex Division Instrumentarium Corp.1993-07-21
K922876AS/3 COP MODULEDatex Division Instrumentarium Corp.1993-07-21
K930303DATASCOPE MULTINEX ID PLUSDatascope Corp.1993-06-16
K914295ANESTHETIC GAS MONITOR TYPE 1304, MODIFIEDBruel & Kjaer1992-04-10
K911644NGM FRAMEDatex Division Instrumentarium Corp.1992-03-04
K911647NGM GAS MODULEDatex Division Instrumentarium Corp.1991-09-19
K903104CAPNOMAC ULTIMA (TM) ANESTHESIA MONITORDatex Division Instrumentarium Corp.1991-01-23
K902021RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITORAlbion Instruments1990-10-09
K892854ANESTHETIC AGENT MONITORCriticare Systems, Inc.1989-10-13

Legacy Summary

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FDA Review

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