The following data is part of a premarket notification filed by Intermedics, Inc. with the FDA for Intermedics Triangle Chest Probe Model 526-04.
| Device ID | K933278 |
| 510k Number | K933278 |
| Device Name: | INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 |
| Classification | Programmer, Pacemaker |
| Applicant | INTERMEDICS, INC. 4000 TECHNOLOGY DR. Angleton, TX 77515 |
| Contact | Todd A Fonseca |
| Correspondent | Todd A Fonseca INTERMEDICS, INC. 4000 TECHNOLOGY DR. Angleton, TX 77515 |
| Product Code | KRG |
| CFR Regulation Number | 870.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-29 |
| Decision Date | 1995-03-15 |