510(k) K812015
K812015 is an FDA 510(k) premarket notification submitted by Sonometrics Systems, Inc. for the device "GLAUKON". The FDA issued a decision of Substantially Equivalent on February 8, 1982. Sonometrics Systems, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 1982
- Date Received
- July 17, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No