RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01— 510(k) K013200

Substantially Equivalent

Rennels Medical Corp.

FDA 510(k) clearance K013200 for RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01, Substantially Equivalent on 2001-12-14. Applicant: Rennels Medical Corp..

Clearance details

Applicant
Rennels Medical Corp.
Product code
Code CAH
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Morganton, NC, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CAH

product code CAH
Death
7
Total
7

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.