Pulmotrack 2020 System

FDA 510(k) K102229 · Karmelsonix

Substantially Equivalent

510(k) numberK102229

Submission

Device name
Pulmotrack 2020 System
Applicant
Karmelsonix
Binyamina, IL
Received
August 9, 2010
Decision date
March 4, 2011
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BZM – Calculator, Pulmonary Function Interpretor (Diagnostic)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1900
Specialty
Anesthesiology

Other 510(k)s with product code BZM

510(k)DeviceApplicantDecision
K090863Personal WheezometerBZM · Traditional Karmelsonix09/21/2009SE
K071955Wim-Pc, Model 1010BZM · Special Karmelsonix11/01/2007SE
K012387STG Multichannel Lung Sound Analysis SystemBZM · Traditional Stethographics, Inc.04/23/2002SE
K980878Pulmotrack,Model 1010BZM · Traditional Karmel Medical Acoustic Technologies , Ltd.12/28/1998SE
K974200Orca Cardiopulmonary Exercise Testing SystemBZM · Traditional Orca Diagnostics Corp.07/21/1998SE
K955432CPX, CCM, Cath with 15% CO2BZM · Traditional Medical Graphics Corp.07/01/1996SE
K923209Medgraphics Exercise ConsultBZM · Traditional Medical Graphics Corp.03/11/1993SE
K911143PB100 Diagnostic SpirometerBZM · Traditional Puritan Bennett Corp.11/29/1991SE
K896345Exercise Evaluation System 2010BZM · Traditional Medical Graphics Corp.01/20/1990SE
K880550Burrows-Knudson Automated Lung Function Inter. SysBZM · Traditional Medimicro Systems, Inc.07/25/1988SE

More from Medimicro Systems, Inc.

510(k)DeviceDecision
K101022Pulmotrack 5050 Wholter, Model 5050DSH · Traditional 07/09/2010SE
K090863Personal WheezometerBZM · Traditional 09/21/2009SE
K071955Wim-Pc, Model 1010BZM · Special 11/01/2007SE

Questions and answers

When was Pulmotrack 2020 System cleared by the FDA?

Pulmotrack 2020 System (K102229) received a 510(k) decision of Substantially Equivalent on March 4, 2011, 207 days after the submission was received.

What is the product code of K102229?

The FDA product code is BZM – Calculator, Pulmonary Function Interpretor (Diagnostic), a Class II (moderate risk) device regulated under 21 CFR 868.1900.