HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004— 510(k) K062664

Substantially Equivalent

Apex Medical Corp.

FDA 510(k) clearance K062664 for HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004, Substantially Equivalent on 2006-12-06. Applicant: Apex Medical Corp..

Clearance details

Applicant: Apex Medical Corp.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2006-09-07
Decision date: 2006-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucheng City, Taipei County, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.