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

AUTOMATIC ELECTRONIC SPHYGMOMANOMETER

K Number: K760738 · Decision Jan 21, 1977
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
2
Review Days
115

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Basic Information

Device Name
AUTOMATIC ELECTRONIC SPHYGMOMANOMETER
K Number
K760738
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1130
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Medical Monitors, Inc.
Date Received
September 28, 1976
Decision Date
January 21, 1977
Product Code
DXN
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
DXN System, Measurement, Blood-Pressure, Non-Invasive

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Other Clearances by Medical Monitors, Inc.

K Number Device Name
K893557 ADAM (ACOUSTICAL DEVICE FOR ANATOMICAL MONITORING)