510(k) K844694
K844694 is an FDA 510(k) premarket notification submitted by Titmus Optical, Inc. for the device "TITMUS VISION TESTER II". The FDA issued a decision of Substantially Equivalent on January 22, 1985. The device falls under product code HIT (Tester, Color Vision), a Class I device regulated under 21 CFR 886.1170. Titmus Optical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 1985
- Date Received
- December 3, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tester, Color Vision
- Device Class
- Class I
- Regulation Number
- 886.1170
- Review Panel
- OP
- Submission Type