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510(k) K895592

FREEWAY NEBULIZER COMPRESSOR by Lifecare Services, Inc. — Product Code CCQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1989
Date Received
September 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Device Class
Class I
Regulation Number
868.5640
Review Panel
AN
Submission Type

Other clearances by Lifecare Services, Inc.

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  • K894779 — LIFECARE NASAL MASK KIT CAT. NO. 06-800 (January 12, 1990)
  • 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)

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  • K961455 — MEDSHIELD/AEROCHAMBER (July 25, 1996)
  • K960593 — SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIR (May 10, 1996)
  • K922033 — SALINE SOLUTION- STERILE (July 21, 1992)
  • K900576 — MODIFIED AEROCHAMBER WITH MASK (May 13, 1991)
  • K900557 — MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER (April 10, 1991)
  • K895115 — FRANK INHALER THERMAL S (May 18, 1990)
  • K894215 — EVOLUTION ULTRASONIC (April 16, 1990)