The following data is part of a premarket notification filed by Medac, Inc. with the FDA for Dispos Gel External Pacing Electrode/low Impedance.
| Device ID | K864985 |
| 510k Number | K864985 |
| Device Name: | DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| 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 | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-22 |
| Decision Date | 1987-03-10 |