The following data is part of a premarket notification filed by Deltex Medical with the FDA for Cardioq, Model 9051-7005.
| Device ID | K031706 |
| 510k Number | K031706 |
| Device Name: | CARDIOQ, MODEL 9051-7005 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | DELTEX MEDICAL TERMINUS RD. Chichester, West Sussex, GB Po19 8tx |
| Contact | Lawerence Brookfield |
| Correspondent | Lawerence Brookfield DELTEX MEDICAL TERMINUS RD. Chichester, West Sussex, GB Po19 8tx |
| Product Code | DPW |
| Subsequent Product Code | DPT |
| Subsequent Product Code | DSA |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-02 |
| Decision Date | 2003-08-06 |
| Summary: | summary |