DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM— 510(k) K813053

Substantially Equivalent

Bentley Laboratories, Inc.

FDA 510(k) clearance K813053 for DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM, Substantially Equivalent on 1981-11-16. Applicant: Bentley Laboratories, Inc..

Clearance details

Applicant: Bentley Laboratories, Inc.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1981-10-29
Decision date: 1981-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.