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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Regulator, Pressure, Gas Cylinder
510(k) Number K921125
Device Name AMBU OXYGEN REGULATOR
Applicant
Amg, LLC
8904 Bash St., Suite A
Indianapolis,  IN  46256
Applicant Contact RICHARD C KLOPSTAD
Correspondent
Amg, LLC
8904 Bash St., Suite A
Indianapolis,  IN  46256
Correspondent Contact RICHARD C KLOPSTAD
Regulation Number868.2700
Classification Product Code
CAN  
Date Received03/10/1992
Decision Date 09/17/1992
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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