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

MEDO BUBBLE BATH MA-80, 400, 600 & 700

K Number: K844064 · Decision Jan 23, 1985
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
72
Applicant Total
2
Review Days
97

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Basic Information

Device Name
MEDO BUBBLE BATH MA-80, 400, 600 & 700
K Number
K844064
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.5100
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Medo U.S.A., Inc.
Date Received
October 18, 1984
Decision Date
January 23, 1985
Product Code
ILJ
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
ILJ Bath, Hydro-Massage

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Other Clearances by Medo U.S.A., Inc.

K Number Device Name
K841235 MEDO MEDOMER MBF-100 II