EMS NASAL CPAP MASK— 510(k) K972605

Substantially Equivalent

Engineered Medical Systems

FDA 510(k) clearance K972605 for EMS NASAL CPAP MASK, Substantially Equivalent on 1998-01-28. Applicant: Engineered Medical Systems.

Clearance details

Applicant: Engineered Medical Systems
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 1997-07-11
Decision date: 1998-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.