MODEL 1700 TRANQUILITY BILEVEL SYSTEM— 510(k) K970173

Substantially Equivalent

Healthdyne Technologies, Inc.

FDA 510(k) clearance K970173 for MODEL 1700 TRANQUILITY BILEVEL SYSTEM, Substantially Equivalent on 1997-04-16. Applicant: Healthdyne Technologies, Inc..

Clearance details

Applicant: Healthdyne Technologies, Inc.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 1997-01-16
Decision date: 1997-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

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Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.