PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM— 510(k) K922668

Substantially Equivalent

Colin Medical Instruments Corp.

FDA 510(k) clearance K922668 for PILOT MODEL 9200 BLOOD PRESSURE MEASUREMENT SYSTEM, Substantially Equivalent on 1997-01-29. Applicant: Colin Medical Instruments Corp..

Clearance details

Applicant: Colin Medical Instruments Corp.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 1992-06-04
Decision date: 1997-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.