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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K171235
Device Name OmniCap
Applicant
Respirion, Inc.
101 N. Chestnut St., Suite 209
Winston-Salem,  NC  27101
Applicant Contact Ed Fadel
Correspondent
ProMedic, LLC
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact Paul Dryden
Regulation Number868.1400
Classification Product Code
CCK  
Date Received04/27/2017
Decision Date 01/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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