MEDISIZE GOLD HEATER AND BOOSTER— 510(k) K070714

Name: FDA 510(k) clearance K070714
Creator: U.S. Food and Drug Administration
Published: 2007-04-30

Substantially Equivalent

Medisize BV

FDA 510(k) clearance K070714 for MEDISIZE GOLD HEATER AND BOOSTER, Substantially Equivalent on 2007-04-30. Applicant: Medisize BV. Device class: 2.

Clearance details

Applicant: Medisize BV
Product code: Code BTT
Device class: Class 2
Regulation: 21 CFR 868.5450
Advisory panel: Anesthesiology
Date received: 2007-03-14
Decision date: 2007-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hillegom, NL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.