MODEL 3200 VASCULAR MINI-LAB— 510(k) K944495

Substantially Equivalent

Parks Medical Electronics, Inc.

FDA 510(k) clearance K944495 for MODEL 3200 VASCULAR MINI-LAB, Substantially Equivalent on 1995-06-02. Applicant: Parks Medical Electronics, Inc..

Clearance details

Applicant: Parks Medical Electronics, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 1994-09-13
Decision date: 1995-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aloha, OR, 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.