The following data is part of a premarket notification filed by Deltex Medical with the FDA for Edm.
| Device ID | K951369 |
| 510k Number | K951369 |
| Device Name: | EDM |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | DELTEX MEDICAL 15825 SHADY GROVE RD. SUITE 70 Rockville, MD 20850 |
| Contact | Glenn A Rahmoeller |
| Correspondent | Glenn A Rahmoeller DELTEX MEDICAL 15825 SHADY GROVE RD. SUITE 70 Rockville, MD 20850 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-27 |
| Decision Date | 1995-11-07 |