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

PHYSIOLOGICAL PRESSURE TRANSDUCER

K Number: K780477 · Decision Apr 13, 1978
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
147
Applicant Total
1
Review Days
20

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Basic Information

Device Name
PHYSIOLOGICAL PRESSURE TRANSDUCER
K Number
K780477
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.2850
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Bell & Howell Instruments
Date Received
March 24, 1978
Decision Date
April 13, 1978
Product Code
DRS
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
DRS Transducer, Blood-Pressure, Extravascular

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