BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX— 510(k) K981745

Substantially Equivalent

Sunscope Intl., Inc.

FDA 510(k) clearance K981745 for BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX, Substantially Equivalent on 1998-07-17. Applicant: Sunscope Intl., Inc..

Clearance details

Applicant: Sunscope Intl., Inc.
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 1998-05-18
Decision date: 1998-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, 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.