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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K121609
Device Name ASTHMAPOLIS SYSTEM
Applicant
RECIPROCAL LABS CORPORATION
612 W. MAIN STREET
STE. 201
MADISON,  WI  53703
Applicant Contact INGER L COUTURE
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/01/2012
Decision Date 07/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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