The following data is part of a premarket notification filed by Deltex Medical Limited with the FDA for Deltex Medical Cardioq-edm, Deltex Medical Cardioq-edm+.
| Device ID | K150347 |
| 510k Number | K150347 |
| Device Name: | Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | DELTEX MEDICAL LIMITED TERMINUS RD. Chichester, GB Po19 8tx |
| Contact | Paul Dwane |
| Correspondent | Neil Armstrong MeddiQuest Limited Quest Science Herlington House, Orton Malborne Peterborough, GB Pe2 5xs |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-11 |
| Decision Date | 2015-07-24 |
| Summary: | summary |