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FDA 510(k) Application Details - K961318
Device Classification Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
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510(K) Number
K961318
Device Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Applicant
INTERTECH RESOURCES, INC.
5100 TICE ST.
FT. MYERS, FL 33905 US
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Contact
AVIA TONEY, RAC
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Regulation Number
868.2600
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Classification Product Code
CAP
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More FDA Info for this Product Code
Date Received
04/05/1996
Decision Date
12/17/1996
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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