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 | K172457 |
| 510k Number | K172457 |
| Device Name: | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | Deltex Medical Limited Terminus Road Chichester, GB Po19 8tx |
| Contact | Mark Baylis |
| Correspondent | Mark Baylis Deltex Medical Limited Terminus Road Chichester, GB Po19 8tx |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-14 |
| Decision Date | 2018-06-28 |
| Summary: | summary |