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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name meter, peak flow, spirometry
510(k) Number K961779
Device Name MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER
Applicant
AVION MEDICAL PRODUCTS, INC.
4361 HARVESTER RD., UNIT 1
BURLINGTON, ONTARIO,  CA L7L 5M4
Applicant Contact ROBERT L JAMES
Correspondent
AVION MEDICAL PRODUCTS, INC.
4361 HARVESTER RD., UNIT 1
BURLINGTON, ONTARIO,  CA L7L 5M4
Correspondent Contact ROBERT L JAMES
Regulation Number868.1860
Classification Product Code
BZH  
Date Received05/08/1996
Decision Date 06/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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