FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

RING-ORIFICE, TURBULENT FLOW PNEUMOT

K Number: K791730 · Decision Nov 16, 1979
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
7
Applicant Total
6
Review Days
80

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Basic Information

Device Name
RING-ORIFICE, TURBULENT FLOW PNEUMOT
K Number
K791730
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.2550
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Research Development Corp.
Date Received
August 28, 1979
Decision Date
November 16, 1979
Product Code
JAX
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
JAX Pneumotachometer

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K Number Device Name
K871870 HSC UNIT ROD
K771407 LUNG VOLUME & PRESSURE MONITOR
K771019 LUNG-MECHANICS MONITOR
K770785 MONITOR, RESPIRATORY, TWO-GAS, RDC
K770061 VO RESPIRATORY PNEUMOTACHOGRAPH