PREEMICARE MODEL D1-X1, SERIES 3000— 510(k) K881476

Substantially Equivalent

Preemicare Corp.

FDA 510(k) clearance K881476 for PREEMICARE MODEL D1-X1, SERIES 3000, Substantially Equivalent on 1988-12-08. Applicant: Preemicare Corp..

Clearance details

Applicant: Preemicare Corp.
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 1988-04-07
Decision date: 1988-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMZ

product code FMZ

Death: 2
Malfunction: 457
Other: 1
Total: 460

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.