YSI MODEL 790 TELE-THERMOMETER— 510(k) K853551

Substantially Equivalent

Yellow Springs Instrument Co., Inc.

FDA 510(k) clearance K853551 for YSI MODEL 790 TELE-THERMOMETER, Substantially Equivalent on 1985-09-19. Applicant: Yellow Springs Instrument Co., Inc..

Clearance details

Applicant
Yellow Springs Instrument Co., Inc.
Product code
Code FLL
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Yellow Springs, OH, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FLL

product code FLL
Death
3
Malfunction
557
Total
560

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.