The following data is part of a premarket notification filed by Life Sensing Instrument Company, Inc. with the FDA for Tele Trens Tm 10.
| Device ID | K960884 |
| 510k Number | K960884 |
| Device Name: | TELE TRENS TM 10 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | LIFE SENSING INSTRUMENT COMPANY, INC. 329 WEST LINCOLN ST. Tullahoma, TN 37388 |
| Contact | B Q Cutshaw |
| Correspondent | B Q Cutshaw LIFE SENSING INSTRUMENT COMPANY, INC. 329 WEST LINCOLN ST. Tullahoma, TN 37388 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-04 |
| Decision Date | 1997-09-12 |