FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM
K Number: K992779
·
Decision Jan 13, 2000
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
72
Applicant Total
4
Review Days
148
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Basic Information
- Device Name
- A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM
- K Number
- K992779
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5100
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medi-Man Rehabilitation Products, Inc.
- Date Received
- August 18, 1999
- Decision Date
- January 13, 2000
- 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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