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

BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005

K Number: K954278 · Decision Oct 2, 1995
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
3
Applicant Total
1
Review Days
19

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Basic Information

Device Name
BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005
K Number
K954278
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.4890
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Beta Medical Products, Inc.
Date Received
September 13, 1995
Decision Date
October 2, 1995
Product Code
MMZ
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
GU
Third Party
N

Classifications

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

Product Code Device Name
MMZ Table, Cystometric, Electric

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