MERCURY MEDICAL T-PIECE RESUSCITATOR— 510(k) K093913

Substantially Equivalent

Mercury Medical, Inc.

FDA 510(k) clearance K093913 for MERCURY MEDICAL T-PIECE RESUSCITATOR, Substantially Equivalent on 2010-04-06. Applicant: Mercury Medical, Inc..

Clearance details

Applicant: Mercury Medical, Inc.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 2009-12-22
Decision date: 2010-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.