The following data is part of a premarket notification filed by Cardiac Resucitator Corp. with the FDA for Pace*aid 10 A -pad 10a- Pacemaker Output Display &.
| Device ID | K850596 |
| 510k Number | K850596 |
| Device Name: | PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY & |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | CARDIAC RESUCITATOR CORP. 25117 S.W. PKWY. Wilsonville, OR 97070 |
| Contact | Jeremiah F O'brien |
| Correspondent | Jeremiah F O'brien CARDIAC RESUCITATOR CORP. 25117 S.W. PKWY. Wilsonville, OR 97070 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-15 |
| Decision Date | 1985-03-06 |