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510(k) K940739

NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR by Newport Medical Instruments, Inc. — Product Code MOD

K940739 is an FDA 510(k) premarket notification submitted by Newport Medical Instruments, Inc. for the device "NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR". The FDA issued a decision of Substantially Equivalent on March 7, 1995. The device falls under product code MOD (Accessory To Continuous Ventilator (Respirator)), a Class II device regulated under 21 CFR 868.5895. Newport Medical Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1995
Date Received
February 17, 1994
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

Other clearances by Newport Medical Instruments, Inc.

  • K121891 — NEWPORT AURA VENTILATOR (November 9, 2012)
  • K111146 — NEWPORT HT70 VENTILATOR (December 1, 2011)
  • K101803 — NEWPORT E360 VENTILATOR (September 8, 2010)
  • K090888 — NEWPORT HT70 FAMILY OF VENTILATORS (November 18, 2009)
  • K082724 — NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM (December 16, 2008)
  • K061094 — NEWPORT E500 WAVE VENTILATOR (July 28, 2006)
  • K053502 — NEWPORT E360 VENTILATOR (January 10, 2006)
  • K041406 — NEWPORT C250 AIR COMPRESSOR MODEL C250 (December 15, 2004)
  • K041082 — NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER (September 7, 2004)
  • K030780 — NEWPORT E500 WAVE VENTILATOR (January 23, 2004)

Other clearances for product code MOD

  • K260051 — CorVision® (91-205-Z0014) (May 12, 2026)
  • K242485 — EveryWare (May 20, 2025)
  • K161411 — Care Cycle Connect Application (February 17, 2017)
  • K091461 — BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE (August 14, 2009)
  • K052751 — VENTLINK SYSTEM (December 23, 2005)
  • 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)

FDA data resources