DIGITAL BPM— 510(k) K790036

Substantially Equivalent

Narco Air-Shields

FDA 510(k) clearance K790036 for DIGITAL BPM, Substantially Equivalent on 1979-03-02. Applicant: Narco Air-Shields.

Clearance details

Applicant: Narco Air-Shields
Product code: Code DXO
Advisory panel: Cardiovascular
Date received: 1979-01-08
Decision date: 1979-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXO

product code DXO

Death: 10
Injury: 156
Malfunction: 884
Total: 1,050

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.