BREATHING CIRCUIT W/HEATED WIRE— 510(k) K880769

Substantially Equivalent

Dryden Corp.

FDA 510(k) clearance K880769 for BREATHING CIRCUIT W/HEATED WIRE, Substantially Equivalent on 1988-08-24. Applicant: Dryden Corp..

Clearance details

Applicant: Dryden Corp.
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 1988-02-29
Decision date: 1988-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.