Home / 510(k) Clearances / K910947

510(k) K910947

NEV-10 NEGATIVE PRESSURE VENTILATOR by Lifecare Services, Inc. — Product Code BYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1991
Date Received
March 6, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Device Class
Class II
Regulation Number
868.5935
Review Panel
AN
Submission Type

Other clearances by Lifecare Services, Inc.

  • K913423 — LIFECARE REMOTE ALARM II (January 30, 1992)
  • K912224 — LIFECARE CPAP-100 (September 23, 1991)
  • K894779 — LIFECARE NASAL MASK KIT CAT. NO. 06-800 (January 12, 1990)
  • K895592 — FREEWAY NEBULIZER COMPRESSOR (November 21, 1989)
  • K894361 — LIFECARE PRESSURE ALARM CAT. NO. 34-010 (October 5, 1989)
  • K880378 — LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001 (September 30, 1988)
  • K873570 — LIFECARE EXHALATION VALVE #06-699 (November 30, 1987)
  • K862212 — LIFECARE REMOTE ALARM #34-001 (June 23, 1986)
  • K842876 — PORTABLE LIFECARE VENTILATOR PLV-102 (August 29, 1984)
  • K832467 — PORTABLE LIFECARE VENTILATOR PLV-100 (October 20, 1983)

Other clearances for product code BYT

  • K082657 — RTX RESPIRATOR (October 8, 2008)
  • K072290 — PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS (May 29, 2008)
  • K924341 — HAYEK OSCILLATOR(TM) (July 21, 1993)
  • K905530 — PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM (March 1, 1991)
  • K902764 — EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM (November 19, 1990)
  • K903745 — THE HAYEK OSCILLATOR (November 9, 1990)
  • K902300 — EASY BREATHER MODEL 100 ACCESSORIES (July 19, 1990)
  • K895849 — RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM (December 22, 1989)
  • K894649 — EMERSON 33-CR CHEST RESPIRATOR (October 13, 1989)
  • K893213 — EASY BREATHER MODEL 100 (August 4, 1989)