The following data is part of a premarket notification filed by Diagnostic Electronics Corp. with the FDA for Micron, Microvascular Doppler.
| Device ID | K860651 |
| 510k Number | K860651 |
| Device Name: | MICRON, MICROVASCULAR DOPPLER |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | DIAGNOSTIC ELECTRONICS CORP. BOX 580 Lexington, MA 02173 |
| Contact | Barbara M Williams |
| Correspondent | Barbara M 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 | 1986-02-21 |
| Decision Date | 1986-07-18 |