DeviceClearance

K883331

Substantially Equivalent

BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10

Applicant
Shiley, Inc.
Product code
DTR
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DTR

product code DTR
Other
1
Total
1

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.