Home / 510(k) Clearances / K895592

510(k) K895592

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

K895592 is an FDA 510(k) premarket notification submitted by Lifecare Services, Inc. for the device "FREEWAY NEBULIZER COMPRESSOR". The FDA issued a decision of Substantially Equivalent on November 21, 1989. The device falls under product code CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)), a Class I device regulated under 21 CFR 868.5640. Lifecare Services, Inc. has at least 10 other 510(k) clearances on record.

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.

  • 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)
  • 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 CCQ

  • K972397 — EZ SPRAY (September 23, 1997)
  • K964956 — E-Z SPACER MASK (SMALL) (April 23, 1997)
  • K961894 — MDI TUTOR (August 14, 1996)
  • 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)

FDA data resources