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

CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON

K Number: K852547 · Decision Nov 10, 1986
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
2
Review Days
514

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Basic Information

Device Name
CORTRONIC APM 770 NONINVASIVE & ARTERIAL PRESS MON
K Number
K852547
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1200
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Cortronic Corp.
Date Received
June 14, 1985
Decision Date
November 10, 1986
Product Code
DQO
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
DQO Catheter, Intravascular, Diagnostic

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Other Clearances by Cortronic Corp.

K Number Device Name
K884911 CORTRONIC SCR1000