PRECISION ONE LIFECARE; DETECTO; DETECTO— 510(k) K130952

Name: FDA 510(k) clearance K130952
Creator: U.S. Food and Drug Administration
Published: 2013-09-26

Substantially Equivalent

Precision One Lifecare, Ltd.

FDA 510(k) clearance K130952 for PRECISION ONE LIFECARE; DETECTO; DETECTO, Substantially Equivalent on 2013-09-26. Applicant: Precision One Lifecare, Ltd.. Device class: 2.

Clearance details

Applicant: Precision One Lifecare, Ltd.
Product code: Code MNW
Device class: Class 2
Regulation: 21 CFR 870.2770
Advisory panel: Cardiovascular
Date received: 2013-04-05
Decision date: 2013-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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