FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEGASUS BIWAVE SYSTEM
K Number: K933004
·
Decision Mar 7, 1994
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
4
Review Days
259
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Basic Information
- Device Name
- PEGASUS BIWAVE SYSTEM
- K Number
- K933004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pegasus Airwave, Inc.
- Date Received
- June 21, 1993
- Decision Date
- March 7, 1994
- Product Code
- FNM
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | FDA class 2 | General Hospital |
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