The following data is part of a premarket notification filed by Medac, Inc. with the FDA for Disposable Gel Defibrillation/external Pacing Elec.
| Device ID | K874447 |
| 510k Number | K874447 |
| Device Name: | DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | MEDAC, INC. 7451 SW COHO CT. Tualatin, OR 97062 |
| Contact | Bob Boonstra |
| Correspondent | Bob Boonstra MEDAC, INC. 7451 SW COHO CT. Tualatin, OR 97062 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-28 |
| Decision Date | 1988-01-27 |