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510(k) K083575

APNEALINK PLUS, MODEL: 22328 by Resmed Germany, Inc. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2009
Date Received
December 3, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Resmed Germany, Inc.

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  • K070263 — APNEALINK (June 15, 2007)
  • K061405 — APNEALINK, MODEL 22302 (July 25, 2006)

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