CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL— 510(k) K881625

Substantially Equivalent

Respiratory Care, Inc.

FDA 510(k) clearance K881625 for CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL, Substantially Equivalent on 1988-06-21. Applicant: Respiratory Care, Inc..

Clearance details

Applicant: Respiratory Care, Inc.
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 1988-04-12
Decision date: 1988-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

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Adverse events under product code BZE

product code BZE

Death: 4
Malfunction: 910
Other: 1
Total: 915

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.