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

BLOOD PRESSURE, DIGITAL MODEL #2153

K Number: K781701 · Decision Dec 4, 1978
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
76
Applicant Total
6
Review Days
55

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Basic Information

Device Name
BLOOD PRESSURE, DIGITAL MODEL #2153
K Number
K781701
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1110
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Sears, Roebuck & Co.
Date Received
October 10, 1978
Decision Date
December 4, 1978
Product Code
DSK
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
DSK Computer, Blood-Pressure

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K Number Device Name
K810635 ELECTRODE BLOOD PRESSURE MONITOR
K800778 DIGITAL ELECTRONIC B.P. MONITOR 2155
K800072 DIGITAL ELECTRONIC EXERCISER/PULSE MTR.
K780986 DIGITAL BLOOD PRESSURE MONITOR
K771666 SPHYGMOMANOMETER #1235