The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Blood Monitoring Unit, Model Bmu 40.
| Device ID | K090147 |
| 510k Number | K090147 |
| Device Name: | BLOOD MONITORING UNIT, MODEL BMU 40 |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Contact | Anastasia Mueller |
| Correspondent | Anastasia Mueller MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2009-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04037691412238 | K090147 | 000 |
| 04037691676203 | K090147 | 000 |
| 04037691469775 | K090147 | 000 |
| 04037691467207 | K090147 | 000 |
| 04037691447445 | K090147 | 000 |