FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SANAR
K Number: K770086
·
Decision Apr 18, 1977
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
4
Applicant Total
4
Review Days
94
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Basic Information
- Device Name
- SANAR
- K Number
- K770086
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5250
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Health Improvement Assoc.
- Date Received
- January 14, 1977
- Decision Date
- April 18, 1977
- Product Code
- IMB
- 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 |
|---|---|---|---|
| IMB | Cabinet, Moist Steam | FDA class 2 | Physical Medicine |
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