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. Device class: 2.

Clearance details

Applicant: Karmelsonix
Product code: Code BZM
Device class: Class 2
Regulation: 21 CFR 868.1900
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 ↗

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More clearances from Karmelsonix

K101022 — PULMOTRACK 5050 WHOLTER, MODEL 50502010-07-09

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