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510(k) K922386

Device
RNA MEDICAL TONOMETER
Applicant
BIONOSTICS, INC.
510(k) number
K922386
Product code
LCH  
Decision
Substantially Equivalent (SESE)
Decision date
1992-06-26
Date received
1992-05-20
Regulation
862.1660
Classification name
Tonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BRUCE R WILLIAMS
Address
Two Craig Rd. Acton MA US 01720 01720

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LCH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K904163CLINICAL BLOOD GAS MIXTURESNorco, Inc.1990-11-01
K900819BLOOD GAS CALIBRATION STANDARDCryogenic Rare Gas Laboratories, Inc.1990-04-25
K862958AMR RESEARCH TONOMETERAssociated Medical Representatives1986-11-24
K841089LINEAR CLOUD TONOMETERLinear Tonometers, Inc.1984-05-22
K802379HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZERAmerican Instrument Co.1980-10-31
K801599CORNING 184 BLOOD GAS TONOMETERCorning Medical & Scientific1980-08-20
K781417PRECISION GAS MIXERMedicor USA , Ltd.1978-09-20
K781386EBS 775 TONOMETEREquilibrated Bio Systems, Inc.1978-09-14

Legacy Summary#

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FDA Review#

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