FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAF-LIFT/SAF-KARY
K Number: K926411
·
Decision Mar 31, 1993
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
20
Applicant Total
6
Review Days
100
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Basic Information
- Device Name
- SAF-LIFT/SAF-KARY
- K Number
- K926411
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5500
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Arjo-Century, Inc.
- Date Received
- December 21, 1992
- Decision Date
- March 31, 1993
- Product Code
- FNG
- 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 |
|---|---|---|---|
| FNG | Lift, Patient, Ac-Powered | FDA class 2 | General Hospital |
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Other Clearances by Arjo-Century, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K930665 | CENTURY BATHING SYSTEM | Aug 28, 1995 | Substantially Equivalent |
| K923637 | ARJO-CENTURY ARM AND LEG TANK SYSTEM | Feb 12, 1993 | Substantially Equivalent |
| K923617 | FULL MOVEMENT THERAPY SYSTEMS | Nov 9, 1992 | Substantially Equivalent |
| K923159 | ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS | Aug 6, 1992 | Substantially Equivalent |
| K920074 | ARJO CENTURY SCALES WITH REMOTE | Apr 6, 1992 | Substantially Equivalent |