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

CIRCAMED MONITOR REMOTE START CONDUCTANCE METER

K Number: K874155 · Decision Nov 23, 1987
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
10
Applicant Total
13
Review Days
41

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Basic Information

Device Name
CIRCAMED MONITOR REMOTE START CONDUCTANCE METER
K Number
K874155
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.2370
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Circadian, Inc.
Date Received
October 13, 1987
Decision Date
November 23, 1987
Product Code
KRC
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
KRC Tester, Electrode, Surface, Electrocardiographic

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Other Clearances by Circadian, Inc.

K Number Device Name
K921878 SCANMATE III
K894956 CIRCAMED HOLTER VERSION 4
K874641 CIRCADIAN STRESS TEST II
K871251 CIRCAMED FULL DISCLOSURE SYSTEM
K860973 CIRCADIAN STRESS TEST SYSTEM
K851517 CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO
K851643 REMOTE CONTROL MODULE
K840741 PULMONARY FUNCTION TESTING STS
K833619 CONDUCTANCE METER
K830830 CIRCA MED TWO-CHANNEL
Search all 13 clearances from Circadian, Inc. →