Lifecare Nasal Mask Kit Cat. No. 06-800

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K894779 ↗

FDA Product Code

BYE

Device Class

Class II

Regulation

21 CFR Part 868.5965

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Nev-10 Negative Pressure Ventilator

  Class II

  FDA 510(k) K910947 Active Cleared 3 Jun 1991

• 6-415 Filter, Element, 170-C

  Class II

  FDA 510(k) K802925 Active Cleared 19 Dec 1980

• Portable Lifecare Ventilator Plv-100

  Class II

  FDA 510(k) K832467 Active Cleared 20 Oct 1983

• Respiraotr, CAM-10 RBL

  Class II

  FDA 510(k) K790605 Active Cleared 3 Jul 1979

• Cam-10 Respiratory Hose Assemblies

  Class I

  FDA 510(k) K801859 Active Cleared 9 Sep 1980

• Lifecare Remote Alarm #34-001

  Class II

  FDA 510(k) K862212 Active Cleared 23 Jun 1986

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