The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Compatibility Ecg Trunk Cables.
| Device ID | K043572 |
| 510k Number | K043572 |
| Device Name: | COMPATIBILITY ECG TRUNK CABLES |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-27 |
| Decision Date | 2005-02-22 |
| Summary: | summary |