MONITORING, PRESSURE KIT— 510(k) K781680

Substantially Equivalent

Pharmaseal Div., Baxter Healthcare Corp.

FDA 510(k) clearance K781680 for MONITORING, PRESSURE KIT, Substantially Equivalent on 1978-10-06. Applicant: Pharmaseal Div., Baxter Healthcare Corp..

Clearance details

Applicant: Pharmaseal Div., Baxter Healthcare Corp.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1978-10-02
Decision date: 1978-10-06
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.