FDA 510(k) clearance · back to tracker

CATHETER, NASAL, OXYGEN

Gainor Medical Europe, Ltd. cleared K902420 on 1991-04-17, decision: substantially equivalent

K-number

K902420

Sponsor

Gainor Medical Europe, Ltd.

Device

CATHETER, NASAL, OXYGEN

Class

Class I

Decision

Substantially Equivalent

Decision date

1991-04-17

Product code

CAT

Advisory committee

Anesthesiology

Medical specialty

Anesthesiology

Regulation number

868.5340

Official FDA record

Open K902420on accessdata.fda.gov →

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

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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.