Home / 510(k) Clearances / K982016

510(k) K982016

PIPER IPPB MODEL 2055 by Vortran Medical Technology 1, Inc. — Product Code NHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1998
Date Received
June 8, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Positive Pressure Breathing, Intermittent
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Vortran Medical Technology 1, Inc.

  • K202219 — VORTRAN GO2VENT with PEEP Valve (February 11, 2021)
  • K182292 — VORTRAN APM-Plus (September 18, 2019)
  • K173914 — VORTRAN Cuff Inflator (VCI) (May 25, 2018)
  • K162968 — VORTRAN GO2VENT (April 10, 2017)
  • K153733 — VORTRAN Manometer (September 16, 2016)
  • K103639 — VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (V (September 15, 2011)
  • K073261 — VAR MONITOR (May 23, 2008)
  • K041473 — VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM (July 15, 2004)
  • K003684 — PERCUSSIVENEB, MODEL PN-2001 (February 23, 2001)
  • K001430 — RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 (July 5, 2000)

Other clearances for product code NHJ

  • K242438 — Clearo (May 16, 2025)
  • K231728 — BiWaze Clear System (April 8, 2024)
  • K213564 — BiWaze Clear System (December 21, 2022)
  • K200988 — Maximus System (May 26, 2020)
  • K191912 — BiWaze Cough (March 27, 2020)
  • K192143 — Maximus System (February 14, 2020)
  • K151689 — MetaNeb 4 System (March 17, 2016)
  • K140598 — PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC (October 16, 2014)
  • K140605 — MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC (October 3, 2014)
  • K132988 — VITAL COUGH (March 28, 2014)