MEDISIZE GOLD HEATER AND BOOSTER T-PIECE— 510(k) K122885

Substantially Equivalent

Medisize BV

FDA 510(k) clearance K122885 for MEDISIZE GOLD HEATER AND BOOSTER T-PIECE, Substantially Equivalent on 2013-08-29. Applicant: Medisize BV.

Clearance details

Applicant: Medisize BV
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2012-09-20
Decision date: 2013-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: The Hague, NL

Download summary PDF View on FDA.gov ↗

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.