510(k) K893968
K893968 is an FDA 510(k) premarket notification submitted by Technitex, Inc. for the device "VKG 2000 VIDEO KERATOMETER". The FDA issued a decision of Substantially Equivalent on September 11, 1989. The device falls under product code HJA (Photokeratoscope), a Class I device regulated under 21 CFR 886.1350. Technitex, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 1989
- Date Received
- June 2, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Photokeratoscope
- Device Class
- Class I
- Regulation Number
- 886.1350
- Review Panel
- OP
- Submission Type