PULMOTRACK 5050 WHOLTER, MODEL 5050— 510(k) K101022

Substantially Equivalent

Karmelsonix

FDA 510(k) clearance K101022 for PULMOTRACK 5050 WHOLTER, MODEL 5050, Substantially Equivalent on 2010-07-09. Applicant: Karmelsonix.

Clearance details

Applicant: Karmelsonix
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2010-04-13
Decision date: 2010-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Binyamina, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.