ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)— 510(k) K970061

Substantially Equivalent

Datascope Corp.

FDA 510(k) clearance K970061 for ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX), Substantially Equivalent on 1997-09-25. Applicant: Datascope Corp..

Clearance details

Applicant: Datascope Corp.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1997-01-07
Decision date: 1997-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramus, NJ, US

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Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.