510(k) K853744
K853744 is an FDA 510(k) premarket notification submitted by Techna Vision for the device "TECHNA VISION, INC.ELECTRIC TABLE". The FDA issued a decision of Substantially Equivalent on October 17, 1985. The device falls under product code HRJ (Table, Instrument, Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.4855. Techna Vision has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 1985
- Date Received
- September 6, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Instrument, Powered, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4855
- Review Panel
- OP
- Submission Type