BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70)— 510(k) K971616

Substantially Equivalent

Data Sciences Intl., Inc.

FDA 510(k) clearance K971616 for BLOOD PRESSURE MEASUREMENT SYSTEM(DSPM-70), Substantially Equivalent on 1998-11-04. Applicant: Data Sciences Intl., Inc..

Clearance details

Applicant: Data Sciences Intl., Inc.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 1997-05-02
Decision date: 1998-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.