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510(k) K143272

ApneaLink Air by Resmed Germany, Inc. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2015
Date Received
November 14, 2014
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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  • K103167 — STELLAR 150 (March 1, 2011)
  • K083575 — APNEALINK PLUS, MODEL: 22328 (March 19, 2009)
  • K070263 — APNEALINK (June 15, 2007)
  • K061405 — APNEALINK, MODEL 22302 (July 25, 2006)

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