FLEXI-SITE SP02 EAR SENSOR— 510(k) K012333

Name: FDA 510(k) clearance K012333
Creator: U.S. Food and Drug Administration
Published: 2001-10-17

Substantially Equivalent

Epic Medical Equipment Services, Inc.

FDA 510(k) clearance K012333 for FLEXI-SITE SP02 EAR SENSOR, Substantially Equivalent on 2001-10-17. Applicant: Epic Medical Equipment Services, Inc.. Device class: 2.

Clearance details

Applicant: Epic Medical Equipment Services, Inc.
Product code: Code DPZ
Device class: Class 2
Regulation: 21 CFR 870.2710
Advisory panel: Cardiovascular
Date received: 2001-07-24
Decision date: 2001-10-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

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