The following data is part of a premarket notification filed by Bistos Co., Ltd. with the FDA for Fetal Monitor, Models Bt-300 And Bt-200.
| Device ID | K052190 |
| 510k Number | K052190 |
| Device Name: | FETAL MONITOR, MODELS BT-300 AND BT-200 |
| Classification | System, Monitoring, Perinatal |
| Applicant | BISTOS CO., LTD. 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Contact | Charlie Mack |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-08-11 |
| Decision Date | 2005-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887529000199 | K052190 | 000 |
| 10887529000103 | K052190 | 000 |
| 30887529000039 | K052190 | 000 |
| 30887529000022 | K052190 | 000 |