FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT
K Number: K915671
·
Decision Jan 13, 1992
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
56
Applicant Total
5
Review Days
49
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Basic Information
- Device Name
- B.A.S.E. BELLOWS AIR SUPPORT EQUIPMENT
- K Number
- K915671
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5170
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Progressive Medical Technology, Inc.
- Date Received
- November 25, 1991
- Decision Date
- January 13, 1992
- Product Code
- IOQ
- 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 |
|---|---|---|---|
| IOQ | Bed, Flotation Therapy, Powered | FDA class 2 | Physical Medicine |
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Other Clearances by Progressive Medical Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923710 | OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED | Mar 22, 1993 | Substantially Equivalent |
| K915638 | TALLEY TM200 INTERMTTENT COMPRESSION UNIT | Feb 11, 1992 | Substantially Equivalent |
| K915092 | TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST | Feb 11, 1992 | Substantially Equivalent |
| K915637 | TALLEY TM500 SEQUENTIAL MULTICOM COMPRESSION SYST. | Feb 11, 1992 | Substantially Equivalent |