510(k) K921214
K921214 is an FDA 510(k) premarket notification submitted by Luneau Ophtalmologie SA for the device "OPHTHALMIC PROJECTOR". The FDA issued a decision of Substantially Equivalent on June 11, 1992. The device falls under product code HOS (Projector, Ophthalmic), a Class I device regulated under 21 CFR 886.1680. Luneau Ophtalmologie SA has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 1992
- Date Received
- March 13, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Projector, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.1680
- Review Panel
- OP
- Submission Type