The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Ultrasonic Blood Level Detector Uld 10-200.
| Device ID | K860076 |
| 510k Number | K860076 |
| Device Name: | GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 |
| Classification | Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Product Code | DTW |
| CFR Regulation Number | 870.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-08 |
| Decision Date | 1986-05-30 |