The following data is part of a premarket notification filed by Tronomed, Inc. with the FDA for Tronomate Patient Cable & Leadwire System.
| Device ID | K952659 |
| 510k Number | K952659 |
| Device Name: | TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | TRONOMED, INC. 32921 CALLE PERFECTO San Juan Capistrano, CA 92675 |
| Contact | James M Arganda |
| Correspondent | James M Arganda TRONOMED, INC. 32921 CALLE PERFECTO San Juan Capistrano, CA 92675 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-12 |
| Decision Date | 1996-01-11 |