510(k) K926412
K926412 is an FDA 510(k) premarket notification submitted by Chiron Vision Corp. for the device "MICRON-SCOPE II". The FDA issued a decision of Substantially Equivalent on July 19, 1994. The device falls under product code HMS (Drum, Eye Knife Test), a Class I device regulated under 21 CFR 886.4230. Chiron Vision Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1994
- Date Received
- December 21, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drum, Eye Knife Test
- Device Class
- Class I
- Regulation Number
- 886.4230
- Review Panel
- OP
- Submission Type