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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 K933889
Device Name PERSONAL BEST LOW RANGE
Applicant
HEALTHSCAN PRODUCTS, INC.
908 POMPTON AVE.
UNIT B2
CEDAR GROVE,  NJ  07009 -1292
Applicant Contact LAUREN R ZIEGLER
Correspondent
HEALTHSCAN PRODUCTS, INC.
908 POMPTON AVE.
UNIT B2
CEDAR GROVE,  NJ  07009 -1292
Correspondent Contact LAUREN R ZIEGLER
Regulation Number868.1860
Classification Product Code
BZH  
Date Received08/10/1993
Decision Date 09/09/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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