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 | Device Class | Medical Specialty |
|---|---|---|---|
| ILJ | Bath, Hydro-Massage | FDA class 2 | Physical Medicine |
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Other Clearances by Medo U.S.A., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841235 | MEDO MEDOMER MBF-100 II | Nov 19, 1984 | Substantially Equivalent |