510(k) K832321
K832321 is an FDA 510(k) premarket notification submitted by Intl. Medical Equipment Corp. for the device "ACCES. HEAD CONTROL-POWERED CHEELCHAIR". The FDA issued a decision of Substantially Equivalent on August 12, 1983. Intl. Medical Equipment Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1983
- Date Received
- July 15, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No