510(k) K781543
K781543 is an FDA 510(k) premarket notification submitted by Sonometrics Systems, Inc. for the device "ORBIOGRAPH". The FDA issued a decision of Substantially Equivalent on October 24, 1978. The device falls under product code HLT (Preamplifier, Ac-Powered, Ophthalmic), a Class II device regulated under 21 CFR 886.1640. Sonometrics Systems, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 1978
- Date Received
- September 8, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Preamplifier, Ac-Powered, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.1640
- Review Panel
- OP
- Submission Type