IQK-200— 510(k) K881313

Substantially Equivalent

Medical Repackers Co.

FDA 510(k) clearance K881313 for IQK-200, Substantially Equivalent on 1988-05-19. Applicant: Medical Repackers Co..

Clearance details

Applicant: Medical Repackers Co.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 1988-03-28
Decision date: 1988-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Payne, AL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

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.