The following data is part of a premarket notification filed by Diagnostic Electronics Corp. with the FDA for Dopplex, Pulsed/continuous Wave Doppoler.
| Device ID | K861023 |
| 510k Number | K861023 |
| Device Name: | DOPPLEX, PULSED/CONTINUOUS WAVE DOPPOLER |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | DIAGNOSTIC ELECTRONICS CORP. BOX 580 Lexington, MA 02173 |
| Contact | Barbara Williams |
| Correspondent | Barbara Williams DIAGNOSTIC ELECTRONICS CORP. BOX 580 Lexington, MA 02173 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-18 |
| Decision Date | 1986-11-17 |