FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BARIAIR
K Number: K955243
·
Decision Oct 23, 1997
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
101
Applicant Total
48
Review Days
708
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Basic Information
- Device Name
- BARIAIR
- K Number
- K955243
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5550
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kinetic Concepts, Inc.
- Date Received
- November 15, 1995
- Decision Date
- October 23, 1997
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FNM), ordered by most recent decision date.
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SIMPULSE
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SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
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Other Clearances by Kinetic Concepts, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050261 | V.A.C. GRANUFOAM SILVER PROTECTION DRESSING | May 26, 2005 | Substantially Equivalent |
| K041642 | V.A.C. GRANUFOAM SILVER DRESSING | Jan 25, 2005 | Substantially Equivalent |
| K032310 | MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS | Oct 10, 2003 | Substantially Equivalent |
| K022011 | V.A.C. ABDOMINAL DRESSING | Feb 26, 2003 | Substantially Equivalent |
| K021500 | VACUUM ASSISTED CLOSURE | Dec 20, 2002 | Substantially Equivalent |
| K021501 | V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT | Dec 2, 2002 | Substantially Equivalent |
| K020781 | WET CHAMBER | May 6, 2002 | Substantially Equivalent |
| K992448 | V.A.C. PLUS | Jan 18, 2000 | Substantially Equivalent |
| K972176 | HOME CARE BEAD BED | Jan 16, 1998 | Substantially Equivalent |
| K972549 | SIMPULSE | Nov 18, 1997 | Substantially Equivalent |