SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS— 510(k) K904777

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K904777 for SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS, Substantially Equivalent on 1991-01-15. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1990-10-22
Decision date: 1991-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

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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.