iPEP System and vPEP— 510(k) K160636

Name: FDA 510(k) clearance K160636
Creator: U.S. Food and Drug Administration
Published: 2016-08-03

Substantially Equivalent

D R Burton Healthcare, LLC

FDA 510(k) clearance K160636 for iPEP System and vPEP, Substantially Equivalent on 2016-08-03. Applicant: D R Burton Healthcare, LLC. Device class: 2.

Clearance details

Applicant: D R Burton Healthcare, LLC
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2016-03-07
Decision date: 2016-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmville, NC, 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.