K930227 is an FDA 510(k) clearance for the MS DISPOSABLE RIGID DOPPLER PROBE. This device is classified as a Flowmeter, Blood, Cardiovascular (Class II - Special Controls, product code DPW).
Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on September 16, 1993, 240 days after receiving the submission on January 19, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K930227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1993 |
| Decision Date | September 16, 1993 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | DPW — Flowmeter, Blood, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2100 |