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FDA 510(k) Application Details - K960851
Device Classification Name
Monitor, Breathing Frequency
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510(K) Number
K960851
Device Name
Monitor, Breathing Frequency
Applicant
PRO-TECH SERVICES, INC.
12826 N.W. 178TH ST., SUITE A
WOODINVILLE, WA 98072 US
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Contact
ANTHONY ZARAGOZA
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Regulation Number
868.2375
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Classification Product Code
BZQ
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More FDA Info for this Product Code
Date Received
03/01/1996
Decision Date
09/17/1996
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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