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510(k) K832467

PORTABLE LIFECARE VENTILATOR PLV-100 by Lifecare Services, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1983
Date Received
August 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
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)
  • K910947 — NEV-10 NEGATIVE PRESSURE VENTILATOR (June 3, 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)

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