TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES— 510(k) K092893

Substantially Equivalent

Tytan Medical Corp.

FDA 510(k) clearance K092893 for TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES, Substantially Equivalent on 2010-01-14. Applicant: Tytan Medical Corp..

Clearance details

Applicant: Tytan Medical Corp.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2009-09-21
Decision date: 2010-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City, TW

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Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.