The following data is part of a premarket notification filed by Boule Medical Ab with the FDA for Medonic M Series.
| Device ID | K083420 |
| 510k Number | K083420 |
| Device Name: | MEDONIC M SERIES |
| Classification | Counter, Differential Cell |
| Applicant | BOULE MEDICAL AB 1800 N.W. 65TH AVE Plantation, FL 33313 |
| Contact | Michael Elliott |
| Correspondent | Michael Elliott BOULE MEDICAL AB 1800 N.W. 65TH AVE Plantation, FL 33313 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-19 |
| Decision Date | 2009-02-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350040796375 | K083420 | 000 |
| 07350040796368 | K083420 | 000 |
| 07350040796351 | K083420 | 000 |
| 07350040796344 | K083420 | 000 |