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510(k) K161411

Care Cycle Connect Application by Respironics, Inc. — Product Code MOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2017
Date Received
May 20, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory To Continuous Ventilator (Respirator)
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

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Other clearances for product code MOD

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  • K052244 — IISIS, VERSION 1.0 (October 13, 2005)
  • K040712 — AIR SAFETY HEPA, MODEL 3500 (June 3, 2004)
  • K022062 — IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 (May 6, 2003)
  • K010401 — TRI-PLEX ADAPTER (October 30, 2002)
  • K011861 — BERNOULLI VENTILATOR MANAGEMENT SYSTEM (November 6, 2001)
  • K963633 — VENTNET; CENTRAL MONITORING STATION (December 16, 1996)
  • K935788 — BICORE SMARTCATH INTRATRACHEAL CATHETER (July 3, 1995)