The following data is part of a premarket notification filed by Medac, Inc. with the FDA for 300m Ecg Monitro/transcutaneous Pacemaker.
| Device ID | K874090 |
| 510k Number | K874090 |
| Device Name: | 300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER |
| 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 | 1987-10-07 |
| Decision Date | 1987-12-15 |