The following data is part of a premarket notification filed by Ipco Corp. with the FDA for Defibrillator, Mark Ii.
| Device ID | K781678 |
| 510k Number | K781678 |
| Device Name: | DEFIBRILLATOR, MARK II |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | IPCO CORP. 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 | 1978-10-02 |
| Decision Date | 1978-12-12 |