The following data is part of a premarket notification filed by Karmel Sonix with the FDA for Wim-pc, Model 1010.
| Device ID | K071955 |
| 510k Number | K071955 |
| Device Name: | WIM-PC, MODEL 1010 |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | KARMEL SONIX 31 HAAVODA ST. Binyamina, IL |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy KARMEL SONIX 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 | 2007-07-16 |
| Decision Date | 2007-11-01 |
| Summary: | summary |