510(k) K827644
K827644 is an FDA 510(k) premarket notification submitted by Technicare Corp. for the device "DELTASCAN HPS CT SCANNER". The FDA issued a decision of Substantially Equivalent on July 22, 1982. Technicare Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 1982
- Date Received
- June 24, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No