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

PREDICTOR

K Number: K871436 · Decision Jun 19, 1987
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
2
Review Days
67

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Basic Information

Device Name
PREDICTOR
K Number
K871436
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1425
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Corazonix Corp.
Date Received
April 13, 1987
Decision Date
June 19, 1987
Product Code
DQK
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
DQK Computer, Diagnostic, Programmable

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Other Clearances by Corazonix Corp.

K Number Device Name
K883855 PREDICTOR II SIGNAL AVERAGING ECG