The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Pulsatile Monitor Plm 10-200.
| Device ID | K842503 |
| 510k Number | K842503 |
| Device Name: | GAMBRO PULSATILE MONITOR PLM 10-200 |
| Classification | Control, Pump Speed, Cardiopulmonary Bypass |
| Applicant | GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWA |
| CFR Regulation Number | 870.4380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-26 |
| Decision Date | 1984-08-10 |