CLINICAL ELECTRONIC THERMOMETERS— 510(k) K882127

Substantially Equivalent

Sheridan Catheter Corp.

FDA 510(k) clearance K882127 for CLINICAL ELECTRONIC THERMOMETERS, Substantially Equivalent on 1988-08-04. Applicant: Sheridan Catheter Corp..

Clearance details

Applicant
Sheridan Catheter Corp.
Product code
Code FLL
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Argyle, NY, 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.