LARYNGOSCOPE RIGID— 510(k) K882433

Substantially Equivalent

Eastmed Enterprises, Inc.

FDA 510(k) clearance K882433 for LARYNGOSCOPE RIGID, Substantially Equivalent on 1988-09-02. Applicant: Eastmed Enterprises, Inc..

Clearance details

Applicant
Eastmed Enterprises, Inc.
Product code
Code CCW
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marlton, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CCW

product code CCW
Death
31
Injury
136
Malfunction
3,703
Other
1
Total
3,871

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.