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

THUMPER MODEL P-1000

K Number: K880597 · Decision Mar 29, 1988
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
55
Applicant Total
2
Review Days
47

Basic Information

Device Name
THUMPER MODEL P-1000
K Number
K880597
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5665
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
MICRO TEK ENGINEERING
Date Received
February 11, 1988
Decision Date
March 29, 1988
Product Code
BYI
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

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

Product Code Device Name
BYI Percussor, Powered-Electric

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K Number Device Name
K880252 THERMAL-PAK MODEL SW 1000