510(k) K833538
K833538 is an FDA 510(k) premarket notification submitted by Vision Health Technology for the device "DOWING OPHTHALMIC CHAIR-NON/AC POWER". The FDA issued a decision of Substantially Equivalent on March 5, 1984. The device falls under product code HMD (Chair, Ophthalmic, Manual), a Class I device regulated under 21 CFR 886.1140. Vision Health Technology has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 1984
- Date Received
- October 5, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chair, Ophthalmic, Manual
- Device Class
- Class I
- Regulation Number
- 886.1140
- Review Panel
- OP
- Submission Type