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

1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER

K Number: K861205 · Decision Jan 5, 1987
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
1
Review Days
280

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Basic Information

Device Name
1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER
K Number
K861205
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.2770
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Valhalla Scientific
Date Received
March 31, 1986
Decision Date
January 5, 1987
Product Code
DSB
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
DSB Plethysmograph, Impedance

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