BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST— 510(k) K921048

Substantially Equivalent

Colin Medical Instruments Corp.

FDA 510(k) clearance K921048 for BP8800T/8000IR/8300G NON-INVASIVE BLOOD PRES. SYST, Substantially Equivalent on 1993-07-01. Applicant: Colin Medical Instruments Corp..

Clearance details

Applicant: Colin Medical Instruments Corp.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1992-03-04
Decision date: 1993-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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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.