FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ISOSTATION KNEE MACHINE (K-100)
K Number: K854621
·
Decision Mar 7, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
6
Review Days
109
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Basic Information
- Device Name
- ISOSTATION KNEE MACHINE (K-100)
- K Number
- K854621
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Isotechnologies, Inc.
- Date Received
- November 18, 1985
- Decision Date
- March 7, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
Other Clearances by Isotechnologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933063 | ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA | Jan 27, 1994 | Substantially Equivalent |
| K912175 | ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE | Jun 7, 1991 | Substantially Equivalent |
| K844060 | ISOSTATION ANKLE/SUBTALAR MACHINE A-100 | Nov 23, 1984 | Substantially Equivalent |
| K842296 | ISOSTATION LOWER BACK MACHINE | Jun 22, 1984 | Substantially Equivalent |
| K841849 | ISOSTATION SHOULDER MACHINE | May 14, 1984 | Substantially Equivalent |