510(k) K781348
K781348 is an FDA 510(k) premarket notification submitted by Metrix Teknika, Inc. for the device "FOCISCAN ECHOVISOR SYSTEM". The FDA issued a decision of Substantially Equivalent on October 3, 1978. Metrix Teknika, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 1978
- Date Received
- August 7, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No