510(k) K883471
K883471 is an FDA 510(k) premarket notification submitted by Technitex, Inc. for the device "VKG 1000, VIDEO KERATOMETER". The FDA issued a decision of Substantially Equivalent on Nov 8, 1988. The device falls under product code HLP (Target, Fusion And Stereoscopic), a Class I device regulated under 21 CFR 886.1880. Technitex, Inc. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 8, 1988
- Date Received
- Aug 16, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Target, Fusion And Stereoscopic
- Device Class
- Class I
- Regulation Number
- 886.1880
- Review Panel
- OP
- Submission Type
- 510(k) Exempt