MERCURY MEDICAL PEEP VALVE— 510(k) K081266

Substantially Equivalent

Mercury Enterprizes Dba Mercury Medical

FDA 510(k) clearance K081266 for MERCURY MEDICAL PEEP VALVE, Substantially Equivalent on 2009-03-05. Applicant: Mercury Enterprizes Dba Mercury Medical.

Clearance details

Applicant
Mercury Enterprizes Dba Mercury Medical
Product code
Code BYE
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Clearwater, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code BYE

product code BYE
Death
5
Total
5

Source: openFDA MAUDE database, through . 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.