The following data is part of a premarket notification filed by Karmelsonix with the FDA for Pulmotrack 2020 System.
| Device ID | K102229 |
| 510k Number | K102229 |
| Device Name: | PULMOTRACK 2020 SYSTEM |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | KARMELSONIX 31 HAAVODA ST. Binyamina, IL |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy KARMELSONIX 31 HAAVODA ST. Binyamina, IL |
| Product Code | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-09 |
| Decision Date | 2011-03-04 |
| Summary: | summary |