EMT-CPAP— 510(k) K021520

Substantially Equivalent

Emergency Medical Techology

FDA 510(k) clearance K021520 for EMT-CPAP, Substantially Equivalent on 2002-07-15. Applicant: Emergency Medical Techology.

Clearance details

Applicant: Emergency Medical Techology
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 2002-05-10
Decision date: 2002-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.