Cleared Special

K102229 - PULMOTRACK 2020 SYSTEM
(FDA 510(k) Clearance)

K102229 · Karmelsonix · Anesthesiology

Mar 2011

Decision

207d

Days

Class 2

Risk

K102229 is an FDA 510(k) clearance for the PULMOTRACK 2020 SYSTEM. This device is classified as a Calculator, Pulmonary Function Interpretor (diagnostic) (Class II — Special Controls, product code BZM).

Submitted by Karmelsonix (Binyamina, IL). The FDA issued a Cleared decision on March 4, 2011, 207 days after receiving the submission on August 9, 2010.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1900.

Submission Details

510(k) Number	K102229 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 09, 2010
Decision Date	March 04, 2011
Days to Decision	207 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF