AIRTEC2 LOW AIR LOSS THERAPY BED— 510(k) K970364

Name: FDA 510(k) clearance K970364
Creator: U.S. Food and Drug Administration
Published: 1997-11-17

Substantially Equivalent

Apex Metal, Inc.

FDA 510(k) clearance K970364 for AIRTEC2 LOW AIR LOSS THERAPY BED, Substantially Equivalent on 1997-11-17. Applicant: Apex Metal, Inc.. Device class: 2.

Clearance details

Applicant: Apex Metal, Inc.
Product code: Code IOQ
Device class: Class 2
Regulation: 21 CFR 890.5170
Advisory panel: Physical Medicine
Date received: 1997-01-31
Decision date: 1997-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt Pleasant, SC, US

Download summary PDF View on FDA.gov ↗

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K970362 — CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM1997-05-16

Adverse events under product code IOQ

product code IOQ

Malfunction: 676
Other: 5
Total: 681

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.