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FDA 510(k) Application Details - K961077
Device Classification Name
Spirometer, Therapeutic (Incentive)
More FDA Info for this Device
510(K) Number
K961077
Device Name
Spirometer, Therapeutic (Incentive)
Applicant
HEALTHSCAN PRODUCTS, INC.
908 POMPTON AVE.
UNIT B2
CEDAR GROVE, NJ 07009-1292 US
Other 510(k) Applications for this Company
Contact
LAUREN R ZIEGLER
Other 510(k) Applications for this Contact
Regulation Number
868.5690
More FDA Info for this Regulation Number
Classification Product Code
BWF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/18/1996
Decision Date
07/15/1996
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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