510(k) K842892
K842892 is an FDA 510(k) premarket notification submitted by Nidek, Inc. for the device "NIDEK DIGITAL KERATOMETER". The FDA issued a decision of Substantially Equivalent on Oct 5, 1984. The device falls under product code HQL (Intraocular Lens), a Class III device regulated under 21 CFR 886.3600. Nidek, Inc. has 76 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 5, 1984
- Date Received
- Jul 23, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Intraocular Lens
- Device Class
- Class III
- Regulation Number
- 886.3600
- Review Panel
- OP
- Submission Type
- PMA