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FDA 510(k) Application Details - K952909
Device Classification Name
Meter, Peak Flow, Spirometry
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510(K) Number
K952909
Device Name
Meter, Peak Flow, Spirometry
Applicant
HEALTHSCAN, INC.
908 POMPTON AVE.
CEDAR GROVE, NJ 07009-1292 US
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Contact
LAUREN R ZIEGLER
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Regulation Number
868.1860
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Classification Product Code
BZH
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More FDA Info for this Product Code
Date Received
06/23/1995
Decision Date
03/29/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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