NIDEK KM-1000 SURGICAL KERATOMETER— 510(k) K862137
Substantially EquivalentNidek, Inc.
FDA 510(k) clearance K862137 for NIDEK KM-1000 SURGICAL KERATOMETER, Substantially Equivalent on 1986-07-23. Applicant: Nidek, Inc.. Device class: 1.
Clearance details
- Applicant
- Nidek, Inc.
- Product code
- Code HLQ
- Device class
- Class 1
- Regulation
- 21 CFR 886.1350
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
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