510(k) K102229
- Device
- PULMOTRACK 2020 SYSTEM
- Applicant
- KARMELSONIX
- 510(k) number
- K102229
- Product code
- BZM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-03-04
- Date received
- 2010-08-09
- Regulation
- 868.1900
- Classification name
- Calculator, Pulmonary Function Interpretor (diagnostic)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- YORAM LEVY
- Address
- 31 Haavoda St. Binyamina IL
FDA Registration Numbers#
- 2023529
- 2183022
Source Documents#
Other 510(k) Records For Product Code BZM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K090863 | PERSONAL WHEEZOMETER | Karmelsonix | 2009-09-21 |
| K071955 | WIM-PC, MODEL 1010 | Karmelsonix | 2007-11-01 |
| K012387 | STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM | Stethographics, Inc. | 2002-04-23 |
| K980878 | PULMOTRACK,MODEL 1010 | Karmel Medical Acoustic Technologies , Ltd. | 1998-12-28 |
| K974200 | ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM | Orca Diagnostics Corp. | 1998-07-21 |
| K955432 | CPX, CCM, CATH WITH 15% CO2 | Medical Graphics Corp. | 1996-07-01 |
| K923209 | MEDGRAPHICS EXERCISE CONSULT | Medical Graphics Corp. | 1993-03-11 |
| K911143 | PB100 DIAGNOSTIC SPIROMETER | Puritan Bennett Corp. | 1991-11-29 |
| K896345 | EXERCISE EVALUATION SYSTEM 2010 | Medical Graphics Corp. | 1990-01-20 |
| K880550 | BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS | Medimicro Systems, Inc. | 1988-07-25 |
| K874902 | SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY | Gomi Medical Instruments | 1988-06-07 |
| K871711 | MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM | Medical Graphics Corp. | 1987-09-25 |
| K864911 | EXERSYSTEM(TM) MMC 5000 | Med Science | 1987-08-21 |
| K863953 | SPIROMETRICS MODEL 2500 FLOWMATE(TM) | Spirometrics, Inc. | 1987-01-15 |
| K864885 | SPIROVISION | Futuremed Div. of Future Impex Corp. | 1987-01-15 |
Legacy Summary#
summary
FDA Review#
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