The following data is part of a premarket notification filed by Medac, Inc. with the FDA for 360d Dc Defibrillator.
| Device ID | K874091 |
| 510k Number | K874091 |
| Device Name: | 360D DC DEFIBRILLATOR |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | MEDAC, INC. 7451 SW COHO CT. Tualatin, OR 97062 |
| Contact | Robert M Boonstra |
| Correspondent | Robert M Boonstra MEDAC, INC. 7451 SW COHO CT. Tualatin, OR 97062 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-07 |
| Decision Date | 1987-11-23 |