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FDA 510(k) Application Details - K001528
Device Classification Name
Spirometer, Diagnostic
More FDA Info for this Device
510(K) Number
K001528
Device Name
Spirometer, Diagnostic
Applicant
SPIROMETRICS MEDICAL EQUIPMENT CO.
49 PLAIN ST.
N. ATTLEBORO, MA 02760-4153 US
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Contact
JAMES R VEALE
Other 510(k) Applications for this Contact
Regulation Number
868.1840
More FDA Info for this Regulation Number
Classification Product Code
BZG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/17/2000
Decision Date
01/18/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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