The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Ms Disposable Rigid Doppler Probe.
| Device ID | K930227 |
| 510k Number | K930227 |
| Device Name: | MS DISPOSABLE RIGID DOPPLER PROBE |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Patricia Christian |
| Correspondent | Patricia Christian MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-19 |
| Decision Date | 1993-09-16 |