K121267 is an FDA 510(k) clearance for the BT-200V VASCULAR DOPPLER. This device is classified as a System, Monitoring, Perinatal (Class II - Special Controls, product code HGM).
Submitted by Bistos Co., Ltd. (Paterson, US). The FDA issued a Cleared decision on August 2, 2012, 98 days after receiving the submission on April 26, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2740.
| 510(k) Number | K121267 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2012 |
| Decision Date | August 02, 2012 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | HGM - System, Monitoring, Perinatal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2740 |