AS7 & AS8 MONITORS— 510(k) K790552

Substantially Equivalent

Narco Air-Shields

FDA 510(k) clearance K790552 for AS7 & AS8 MONITORS, Substantially Equivalent on 1979-05-01. Applicant: Narco Air-Shields.

Clearance details

Applicant: Narco Air-Shields
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1979-03-20
Decision date: 1979-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.