The following data is part of a premarket notification filed by Ad Elektronik Gmbh with the FDA for Highpak-12.
| Device ID | K062331 |
| 510k Number | K062331 |
| Device Name: | HIGHPAK-12 |
| Classification | Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator |
| Applicant | AD ELEKTRONIK GMBH 3924 CASCADE BEACH ROAD Lutsen, MN 55612 -9532 |
| Contact | Gregory J Mathison |
| Correspondent | Gregory J Mathison AD ELEKTRONIK GMBH 3924 CASCADE BEACH ROAD Lutsen, MN 55612 -9532 |
| Product Code | MPD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-10 |
| Decision Date | 2007-07-10 |
| Summary: | summary |