The following data is part of a premarket notification filed by Transtracheal Systems with the FDA for Transkinetics Rado Freq Multi-lead Tele Syst 7200.
| Device ID | K904749 |
| 510k Number | K904749 |
| Device Name: | TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200 |
| Classification | Amplifier And Signal Conditioner, Transducer Signal |
| Applicant | TRANSTRACHEAL SYSTEMS 110 SHAWMUT RD. Canton, MA 02021 |
| Contact | John G Gregory |
| Correspondent | John G Gregory TRANSTRACHEAL SYSTEMS 110 SHAWMUT RD. Canton, MA 02021 |
| Product Code | DRQ |
| CFR Regulation Number | 870.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-19 |
| Decision Date | 1991-03-01 |