FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOME CARE BEAD BED
K Number: K972176
·
Decision Jan 16, 1998
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
27
Applicant Total
48
Review Days
221
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Basic Information
- Device Name
- HOME CARE BEAD BED
- K Number
- K972176
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5160
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kinetic Concepts, Inc.
- Date Received
- June 9, 1997
- Decision Date
- January 16, 1998
- Product Code
- INX
- 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 |
|---|---|---|---|
| INX | Bed, Air Fluidized | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
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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 |
| K972549 | SIMPULSE | Nov 18, 1997 | Substantially Equivalent |
| K955243 | BARIAIR | Oct 23, 1997 | Substantially Equivalent |