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FDA 510(k) Application Details - K213948
Device Classification Name
Analyzer, Gas, Oxygen, Gaseous-Phase
More FDA Info for this Device
510(K) Number
K213948
Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant
Bio-Med Devices, Inc.
61 Soundview Rd
Guilford, CT 06437 US
Other 510(k) Applications for this Company
Contact
Ken K Close
Other 510(k) Applications for this Contact
Regulation Number
868.1720
More FDA Info for this Regulation Number
Classification Product Code
CCL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/17/2021
Decision Date
03/17/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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