REVIVATOR— 510(k) K094003

Name: FDA 510(k) clearance K094003
Creator: U.S. Food and Drug Administration
Published: 2010-09-17

Substantially Equivalent

Hersill, S.L.

FDA 510(k) clearance K094003 for REVIVATOR, Substantially Equivalent on 2010-09-17. Applicant: Hersill, S.L.. Device class: 2.

Clearance details

Applicant: Hersill, S.L.
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 2009-12-28
Decision date: 2010-09-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mostoles ( Madrid), ES

Download summary PDF View on FDA.gov ↗

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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.