The following data is part of a premarket notification filed by Bistos Co., Ltd. with the FDA for Bt-200v Vascular Doppler.
| Device ID | K121267 |
| 510k Number | K121267 |
| Device Name: | BT-200V VASCULAR DOPPLER |
| Classification | System, Monitoring, Perinatal |
| Applicant | BISTOS CO., LTD. 111 ELLISON STREET Paterson, NJ 07505 |
| Contact | Young Chi |
| Correspondent | Young Chi BISTOS CO., LTD. 111 ELLISON STREET Paterson, NJ 07505 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-26 |
| Decision Date | 2012-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30887529000015 | K121267 | 000 |