PORTABLE LIFECARE VENTILATOR PLV-100— 510(k) K832467

Name: FDA 510(k) clearance K832467
Creator: U.S. Food and Drug Administration
Published: 1983-10-20

Substantially Equivalent

Lifecare Services, Inc.

FDA 510(k) clearance K832467 for PORTABLE LIFECARE VENTILATOR PLV-100, Substantially Equivalent on 1983-10-20. Applicant: Lifecare Services, Inc.. Device class: 2.

Clearance details

Applicant: Lifecare Services, Inc.
Product code: Code CBK
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 1983-08-02
Decision date: 1983-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K913423 — LIFECARE REMOTE ALARM II1992-01-30
K912224 — LIFECARE CPAP-1001991-09-23
K910947 — NEV-10 NEGATIVE PRESSURE VENTILATOR1991-06-03
K894779 — LIFECARE NASAL MASK KIT CAT. NO. 06-8001990-01-12
K895592 — FREEWAY NEBULIZER COMPRESSOR1989-11-21

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.