510(k) K854162
K854162 is an FDA 510(k) premarket notification submitted by Healthmate, Inc. for the device "SUPPORT ARM". The FDA issued a decision of Substantially Equivalent on December 9, 1985. Healthmate, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1985
- Date Received
- October 15, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No