FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

BLOOD GAS MIXTURE

K Number: K822753 · Decision Oct 22, 1982
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
31
Applicant Total
5
Review Days
39

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
BLOOD GAS MIXTURE
K Number
K822753
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.6400
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Liquid Carbonic Corp.
Date Received
September 13, 1982
Decision Date
October 22, 1982
Product Code
BXK
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
BXK Gas, Calibration (Specified Concentration)

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (BXK), ordered by most recent decision date.

View all

Other Clearances by Liquid Carbonic Corp.

K Number Device Name
K822764 LUNG DIFFUSION MIXTURE
K822762 CLINICAL GAS MIXTURE-FLAMMABLE
K822763 CLINICAL GAS MIXTURE-NON-FLAMMABLE
K822752 ANAEROBIC CARBON DIOXIDE