DIGITAL SPHYGMOMANOMETER— 510(k) K871371

Substantially Equivalent

Omron Tateisi Electronics Co.

FDA 510(k) clearance K871371 for DIGITAL SPHYGMOMANOMETER, Substantially Equivalent on 1987-06-12. Applicant: Omron Tateisi Electronics Co..

Clearance details

Applicant: Omron Tateisi Electronics Co.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1987-04-07
Decision date: 1987-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, 105 Japan, JP

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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.