The following data is part of a premarket notification filed by Deltex Medical Limited with the FDA for Deltex Medical Cardioq Edm.
| Device ID | K111542 |
| 510k Number | K111542 |
| Device Name: | DELTEX MEDICAL CARDIOQ EDM |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | DELTEX MEDICAL LIMITED BIOPARK, BROADWATER ROAD WELWYN GARDEN CITY Hertsfordshire, GB Al7 3ax |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong DELTEX MEDICAL LIMITED BIOPARK, BROADWATER ROAD WELWYN GARDEN CITY Hertsfordshire, GB Al7 3ax |
| 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 | 2011-06-02 |
| Decision Date | 2011-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055679404319 | K111542 | 000 |