The following data is part of a premarket notification filed by Eurotrol B.v. with the FDA for Hemotrol Wb - Low, Hemotrol Wb - Normal, Hemotrol Wb - High.
| Device ID | K182744 |
| 510k Number | K182744 |
| Device Name: | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High |
| Classification | Control, Hemoglobin |
| Applicant | EUROTROL B.V. Keplerlaan 20 Ede, NL 6716bs |
| Contact | Mylene De Boer |
| Correspondent | Mylene De Boer EUROTROL B.V. Keplerlaan 20 Ede, NL 6716bs |
| Product Code | GGM |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2019-02-01 |
| Summary: | summary |