FIRST MEDIC MODEL 610P— 510(k) K895185

Substantially Equivalent

First Medical Devices Corp.

FDA 510(k) clearance K895185 for FIRST MEDIC MODEL 610P, Substantially Equivalent on 1989-10-27. Applicant: First Medical Devices Corp..

Clearance details

Applicant: First Medical Devices Corp.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1989-08-11
Decision date: 1989-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.