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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, Oxygen, Gaseous-Phase
510(k) Number K213948
Device Name OxyMinder
Applicant
Bio-Med Devices, Inc.
61 Soundview Rd
Guilford,  CT  06437
Applicant Contact Ken K Close
Correspondent
ProMedic Consulting LLC
131 Bay Point Dr NE
Saint Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.1720
Classification Product Code
CCL  
Date Received12/17/2021
Decision Date 03/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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