The following data is part of a premarket notification filed by Deltex Medical Limited with the FDA for Deltex Medical Cardioq-edm+.
| Device ID | K132139 |
| 510k Number | K132139 |
| Device Name: | DELTEX MEDICAL CARDIOQ-EDM+ |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | DELTEX MEDICAL LIMITED 11440 W. BERNARDO CT. SUITE 300 San Diego, CA 92127 |
| Contact | Ronald S Warren |
| Correspondent | Ronald S Warren DELTEX MEDICAL LIMITED 11440 W. BERNARDO CT. SUITE 300 San Diego, CA 92127 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-11 |
| Decision Date | 2013-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055679404326 | K132139 | 000 |