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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K061283
Device Name PULMOLIFE
Applicant
Micro Medical, Ltd.
Quayside
Chatham Maritime
Chatham, Kent,  GB ME4 4QY
Applicant Contact GLEN HILLSLEY
Correspondent
Micro Medical, Ltd.
Quayside
Chatham Maritime
Chatham, Kent,  GB ME4 4QY
Correspondent Contact GLEN HILLSLEY
Regulation Number868.1840
Classification Product Code
BZG  
Date Received05/08/2006
Decision Date 12/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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