The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Post Extra Systolic Postentlator.
| Device ID | K791959 |
| 510k Number | K791959 |
| Device Name: | POST EXTRA SYSTOLIC POSTENTLATOR |
| Classification | Synchronizer, Ecg / Respirator, Radiographic |
| Applicant | MEDRAD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IXO |
| CFR Regulation Number | 892.1970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-01 |
| Decision Date | 1980-01-09 |