FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

TEXAS INTERFACE PRESSURE EVALUATOR-TIPE

K Number: K831800 · Decision Aug 16, 1983
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
10
Applicant Total
1
Review Days
85

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Basic Information

Device Name
TEXAS INTERFACE PRESSURE EVALUATOR-TIPE
K Number
K831800
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
890.1600
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Tee-Kay Applied Technology
Date Received
May 23, 1983
Decision Date
August 16, 1983
Product Code
JFC
Advisory Committee
Physical Medicine
Review Advisory Committee
PM
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
JFC System, Pressure Measurement, Intermittent

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