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510(k) K092685

PNEUMOTHERML, MODEL: 5800 by Salter Labs — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2009
Date Received
September 2, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

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