BLOOD PRESSURE MONITORING KITS,WALRUS— 510(k) K830754

Substantially Equivalent

Medical Parameters, Inc.

FDA 510(k) clearance K830754 for BLOOD PRESSURE MONITORING KITS,WALRUS, Substantially Equivalent on 1983-08-12. Applicant: Medical Parameters, Inc..

Clearance details

Applicant: Medical Parameters, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1983-03-10
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.