FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100
K Number: K963777
·
Decision Jul 28, 1997
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
22
Applicant Total
4
Review Days
311
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Basic Information
- Device Name
- HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-100
- K Number
- K963777
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5650
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Stephenson Industries, Inc.
- Date Received
- September 20, 1996
- Decision Date
- July 28, 1997
- Product Code
- KPJ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KPJ | Chamber, Oxygen, Topical, Extremity | FDA class 2 | General, Plastic Surgery |
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