The following data is part of a premarket notification filed by Karmelsonix with the FDA for Pulmotrack 5050 Wholter, Model 5050.
| Device ID | K101022 |
| 510k Number | K101022 |
| Device Name: | PULMOTRACK 5050 WHOLTER, MODEL 5050 |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | KARMELSONIX 31 HAAVODA ST. Binyamina, IL |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy KARMELSONIX 31 HAAVODA ST. Binyamina, IL |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-13 |
| Decision Date | 2010-07-09 |
| Summary: | summary |