The following data is part of a premarket notification filed by Bistos Co., Ltd. with the FDA for Fetal Monitor Model: Bt-200t.
| Device ID | K100885 |
| 510k Number | K100885 |
| Device Name: | FETAL MONITOR MODEL: BT-200T |
| 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 | 2010-03-30 |
| Decision Date | 2010-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30887529000046 | K100885 | 000 |