The following data is part of a premarket notification filed by L.d. Technology, Llc with the FDA for E.s Teck ( Electro Sensor Teck).
| Device ID | K083229 |
| 510k Number | K083229 |
| Device Name: | E.S TECK ( ELECTRO SENSOR TECK) |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | L.D. TECHNOLOGY, LLC 11459 NW 34 STREET Miami, FL 33178 |
| Contact | Richard Clement |
| Correspondent | Richard Clement L.D. TECHNOLOGY, LLC 11459 NW 34 STREET Miami, FL 33178 |
| Product Code | MWI |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | JOM |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-03 |
| Decision Date | 2009-02-23 |
| Summary: | summary |