510(k) K854621
K854621 is an FDA 510(k) premarket notification submitted by Isotechnologies, Inc. for the device "ISOSTATION KNEE MACHINE (K-100)". The FDA issued a decision of Substantially Equivalent on March 7, 1986. Isotechnologies, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 1986
- Date Received
- November 18, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No