The following data is part of a premarket notification filed by Medical Research Laboratories, Inc. with the FDA for Porta Pulse Iii #d320.
| Device ID | K833751 |
| 510k Number | K833751 |
| Device Name: | PORTA PULSE III #D320 |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | MEDICAL RESEARCH LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-26 |
| Decision Date | 1984-01-11 |