PULMOTRACK 2020 SYSTEM— 510(k) K102229

Substantially Equivalent

Karmelsonix

FDA 510(k) clearance K102229 for PULMOTRACK 2020 SYSTEM, Substantially Equivalent on 2011-03-04. Applicant: Karmelsonix.

Clearance details

Applicant: Karmelsonix
Product code: Code BZM
Advisory panel: Anesthesiology
Date received: 2010-08-09
Decision date: 2011-03-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Binyamina, IL

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.