The following data is part of a premarket notification filed by Gambro Healthcare with the FDA for Gambro Dqm 200.
| Device ID | K990039 |
| 510k Number | K990039 |
| Device Name: | GAMBRO DQM 200 |
| Classification | Conductivity Rate, Urea Nitrogen |
| Applicant | GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
| Product Code | LFP |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-06 |
| Decision Date | 2000-01-27 |
| Summary: | summary |