BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10— 510(k) K883331

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K883331 for BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10, Substantially Equivalent on 1988-09-26. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 1988-08-08
Decision date: 1988-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

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.