OPD-SCAN, MODELS ARK-10000 AND ARK-9000— 510(k) K003299

Unknown

Nidek Co., Ltd.

FDA 510(k) clearance K003299 for OPD-SCAN, MODELS ARK-10000 AND ARK-9000, Unknown on 2001-03-09. Applicant: Nidek Co., Ltd.. Device class: 1.

Clearance details

Applicant: Nidek Co., Ltd.
Product code: Code HLQ
Device class: Class 1
Regulation: 21 CFR 886.1350
Advisory panel: Ophthalmic
Date received: 2000-10-20
Decision date: 2001-03-09
Decision: Unknown
Clearance type: Traditional
Location: Lake Forest, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.