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510(k) K061405

APNEALINK, MODEL 22302 by Resmed Germany, Inc. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2006
Date Received
May 19, 2006
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)

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