The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Blood Level Detector Lcs 10.
| Device ID | K822821 |
| 510k Number | K822821 |
| Device Name: | GAMBRO BLOOD LEVEL DETECTOR LCS 10 |
| Classification | Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
| Applicant | GAMBRO, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTW |
| CFR Regulation Number | 870.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-20 |
| Decision Date | 1982-10-18 |