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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K220311
Device Name Cardiovascular Angiography System
Applicant
Allengers Medical Systems Limited
Fda Hall Unit-2, Bhankarpur, Mubarakpur Rd.
Derabassi, Distt. Mohali,  IN 140507
Applicant Contact Sanjeev K. Marjara
Correspondent
Allengers Medical Systems Limited
Fda Hall Unit-2, Bhankarpur, Mubarakpur Rd.
Derabassi, Distt. Mohali,  IN 140507
Correspondent Contact Sanjeev K. Marjara
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received02/02/2022
Decision Date 05/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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