FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

VARITEST

K Number: K882547 · Decision Nov 3, 1988
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
1
Review Days
135

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Basic Information

Device Name
VARITEST
K Number
K882547
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.2780
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Eureka AB
Date Received
June 21, 1988
Decision Date
November 3, 1988
Product Code
JOM
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
JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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