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

SPHYGMOMANOMETER #1235

K Number: K771666 · Decision Sep 30, 1977
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
6
Review Days
30

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Basic Information

Device Name
SPHYGMOMANOMETER #1235
K Number
K771666
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1435
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Sears, Roebuck & Co.
Date Received
August 31, 1977
Decision Date
September 30, 1977
Product Code
DXG
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
DXG Computer, Diagnostic, Pre-Programmed, Single-Function

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K780986 DIGITAL BLOOD PRESSURE MONITOR