FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PULSAIR MODEL SP-1
K Number: K832177
·
Decision Dec 9, 1983
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
6
Applicant Total
1
Review Days
156
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Basic Information
- Device Name
- PULSAIR MODEL SP-1
- K Number
- K832177
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5950
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Thermowave Medical Device Corp.
- Date Received
- July 6, 1983
- Decision Date
- December 9, 1983
- Product Code
- IRQ
- 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 |
|---|---|---|---|
| IRQ | Unit, Heating, Powered | FDA class 1 | Physical Medicine |
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