FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
K Number: K121929
·
Decision Jan 17, 2013
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
4
Applicant Total
10
Review Days
199
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Basic Information
- Device Name
- ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
- K Number
- K121929
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6775
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diacor, Inc.
- Date Received
- July 2, 2012
- Decision Date
- January 17, 2013
- Product Code
- FRZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| FRZ | Device, Patient Transfer, Powered | FDA class 2 | General Hospital |
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Other Clearances by Diacor, Inc.
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|---|---|---|---|
| K050888 | INTEGRA IMMOBILIZATION SYSTEM | May 23, 2005 | Substantially Equivalent |
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| K953046 | PERI-PUSHER | Sep 22, 1995 | Substantially Equivalent |
| K950112 | CENTRALITE(R)-DLL SERIES | Aug 16, 1995 | Substantially Equivalent |
| K934566 | RADASSIST | Nov 3, 1993 | Substantially Equivalent |
| K930246 | MAMMORX | Jul 26, 1993 | Substantially Equivalent |
| K893398 | CENTRALITE BACKPOINTER | Aug 17, 1989 | Substantially Equivalent |
| K872489 | CENTRALITE | Jul 15, 1987 | Substantially Equivalent |
| K860193 | PORTALCAST | Jan 30, 1986 | Substantially Equivalent |