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

INTERVAL TIMER MODEL V4295

K Number: K790203 · Decision Mar 2, 1979
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
23
Applicant Total
9
Review Days
31

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Basic Information

Device Name
INTERVAL TIMER MODEL V4295
K Number
K790203
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.2050
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Electronics For Medicine, Inc.
Date Received
January 30, 1979
Decision Date
March 2, 1979
Product Code
DRR
Advisory Committee
Cardiovascular
Review Advisory Committee
CV
Third Party
N

Classifications

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

Product Code Device Name
DRR Amplifier And Signal Conditioner, Biopotential

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K791006 SMART BILECTRODES
K790198 MONITOR PLUG-IN MODEL M1106 ECG
K790185 MODEL V 4207 INTEGRATING PLUG-IN
K780107 ANALYZER-PLUG-IN, CO2 MODEL M 3104
K770366 ISOLATED ELECTROCARDIOGRAPH MODEL 1207