510(k) K890509
K890509 is an FDA 510(k) premarket notification submitted by Biophysic Medical, Inc. for the device "INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 24, 1989. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Biophysic Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 1989
- Date Received
- February 1, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.4390
- Review Panel
- OP
- Submission Type