AMBU NEONATE SILICONE RESUSCITATOR— 510(k) K993278

Name: FDA 510(k) clearance K993278
Creator: U.S. Food and Drug Administration
Published: 2000-05-17

Substantially Equivalent

Ambu, Inc.

FDA 510(k) clearance K993278 for AMBU NEONATE SILICONE RESUSCITATOR, Substantially Equivalent on 2000-05-17. Applicant: Ambu, Inc.. Device class: 2.

Clearance details

Applicant: Ambu, Inc.
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 1999-09-30
Decision date: 2000-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Linthicum, MD, US

Download summary PDF View on FDA.gov ↗

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K051529 — AMBU NEUROLINE GROUND2005-08-04
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K041734 — AMBU DISPOSABLE ECG ELECTRODE2004-09-22
K040991 — AMBU DISPOSABLE PRESSURE MANOMETER2004-07-22

Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.