TAP-T— 510(k) K061732

Substantially Equivalent

Airway Management, Inc.

FDA 510(k) clearance K061732 for TAP-T, Substantially Equivalent on 2006-07-12. Applicant: Airway Management, Inc..

Clearance details

Applicant
Airway Management, Inc.
Product code
Code LRK
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Dallas, TX, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LRK

product code LRK
Injury
246
Malfunction
1,044
Total
1,290

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.