The following data is part of a premarket notification filed by Bistos Co., Ltd. with the FDA for Bt-350.
| Device ID | K103545 |
| 510k Number | K103545 |
| Device Name: | BT-350 |
| Classification | System, Monitoring, Perinatal |
| Applicant | BISTOS CO., LTD. 4802 GLENWOOD ROAD Brooklyn, NY 11234 |
| Contact | Steve Kohn |
| Correspondent | Steve Kohn BISTOS CO., LTD. 4802 GLENWOOD ROAD Brooklyn, NY 11234 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-02 |
| Decision Date | 2011-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887529000066 | K103545 | 000 |
| 10887529000059 | K103545 | 000 |