DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR— 510(k) K862119

Substantially Equivalent

Parke-Davis Co.

FDA 510(k) clearance K862119 for DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR, Substantially Equivalent on 1986-08-29. Applicant: Parke-Davis Co..

Clearance details

Applicant: Parke-Davis Co.
Product code: Code DYG
Advisory panel: Cardiovascular
Date received: 1986-06-03
Decision date: 1986-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.