The following data is part of a premarket notification filed by Cardiac Control Systems, Inc. with the FDA for Maestro Pacemaker Test Magnet.
| Device ID | K895110 |
| 510k Number | K895110 |
| Device Name: | MAESTRO PACEMAKER TEST MAGNET |
| Classification | Magnet, Test, Pacemaker |
| Applicant | CARDIAC CONTROL SYSTEMS, INC. 3 COMMERCE BLVD. Palm Coast, FL 32164 |
| Contact | Scott Mindrebo |
| Correspondent | Scott Mindrebo CARDIAC CONTROL SYSTEMS, INC. 3 COMMERCE BLVD. Palm Coast, FL 32164 |
| Product Code | DTG |
| CFR Regulation Number | 870.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-15 |
| Decision Date | 1989-09-26 |