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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 K944120
Device Name FI02 SENSING MODULE
Applicant
Core-M, L.P.
129 Braintree St.
Allston,  MA  02134
Applicant Contact NATAN E PARSONS
Correspondent
Core-M, L.P.
129 Braintree St.
Allston,  MA  02134
Correspondent Contact NATAN E PARSONS
Regulation Number868.1720
Classification Product Code
CCL  
Date Received08/23/1994
Decision Date 05/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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