STATUS DS OXY— 510(k) K130650

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K130650 for STATUS DS OXY, Substantially Equivalent on 2014-02-26. Applicant: Princeton BioMeditech Corp.. Device class: 2.

Clearance details

Applicant: Princeton BioMeditech Corp.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2013-03-11
Decision date: 2014-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monmouth Junction, NJ, US

Download summary PDF View on FDA.gov ↗

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