PREEMICARE NEBUTECH NEBULIZER SYSTEM— 510(k) K896375

Name: FDA 510(k) clearance K896375
Creator: U.S. Food and Drug Administration
Published: 1990-10-29

Substantially Equivalent

Preemicare Corp.

FDA 510(k) clearance K896375 for PREEMICARE NEBUTECH NEBULIZER SYSTEM, Substantially Equivalent on 1990-10-29. Applicant: Preemicare Corp.. Device class: 2.

Clearance details

Applicant: Preemicare Corp.
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 1989-11-06
Decision date: 1990-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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K911450 — INFANT VENTILATOR1991-06-18
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K893622 — PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.1990-01-03
K893624 — PREEMICARE MODEL 2500 TRANSPORT WARMER1989-09-27
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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.