FDA 510(k) clearance · back to tracker

IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM

Par Microsystems Corp. cleared K870039 on 1987-02-12, decision: substantially equivalent

K-number

K870039

Sponsor

Par Microsystems Corp.

Device

IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM

Class

Class I

Decision

Substantially Equivalent

Decision date

1987-02-12

Product code

DSF

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.2810

Official FDA record

Open K870039on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.