FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇺 Australia
DONWAY LIFTING FRAME
K Number: K851660
·
Decision Aug 7, 1985
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
38
Applicant Total
5
Review Days
106
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Basic Information
- Device Name
- DONWAY LIFTING FRAME
- K Number
- K851660
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6900
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Australian Biomedical Corporation , Ltd.
- Date Received
- April 23, 1985
- Decision Date
- August 7, 1985
- Product Code
- FPP
- 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 |
|---|---|---|---|
| FPP | Stretcher, Hand-Carried | FDA class 1 | General Hospital |
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Other Clearances by Australian Biomedical Corporation , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K871735 | VOROSCOPE(TM) | Jun 3, 1987 | Substantially Equivalent |
| K862457 | LYNX EL MICROSCOPY TISSUE PROCESSOR | Jul 16, 1986 | Substantially Equivalent |
| K853114 | ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR | Aug 6, 1985 | Substantially Equivalent |
| K843522 | DONWAY SPLINT | Feb 7, 1985 | Substantially Equivalent |