CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM— 510(k) K970362

Substantially Equivalent

Apex Metal, Inc.

FDA 510(k) clearance K970362 for CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM, Substantially Equivalent on 1997-05-16. Applicant: Apex Metal, Inc..

Clearance details

Applicant: Apex Metal, Inc.
Product code: Code FNM
Advisory panel: General Hospital
Date received: 1997-01-31
Decision date: 1997-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

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.