FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUPERIOR BATH, MODEL 6300
K Number: K012061
·
Decision Jul 19, 2001
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
72
Applicant Total
3
Review Days
17
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Basic Information
- Device Name
- SUPERIOR BATH, MODEL 6300
- K Number
- K012061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5100
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Penner Manufacturing, Inc.
- Date Received
- July 2, 2001
- Decision Date
- July 19, 2001
- Product Code
- ILJ
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- Y
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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