510(k) K000544
K000544 is an FDA 510(k) premarket notification submitted by Labtician Ophthalmics, Inc. for the device "BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080". The FDA issued a decision of Substantially Equivalent on March 9, 2000. The device falls under product code HJX (Reader, Prism, Ophthalmic), a Class I device regulated under 21 CFR 886.5810. Labtician Ophthalmics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 2000
- Date Received
- February 18, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reader, Prism, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.5810
- Review Panel
- OP
- Submission Type