The following data is part of a premarket notification filed by Bistos Co., Ltd. with the FDA for Model Bt-220l And Bt-220c.
| Device ID | K142799 |
| 510k Number | K142799 |
| Device Name: | Model BT-220L And BT-220C |
| Classification | System, Monitoring, Perinatal |
| Applicant | Bistos Co., Ltd. 27 New England Drive Ramsey, NJ 07446 |
| Contact | Young Chi |
| Correspondent | Young Chi Bistos Co., Ltd. 27 New England Drive Ramsey, NJ 07446 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-29 |
| Decision Date | 2015-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30887529000091 | K142799 | 000 |
| 30887529000084 | K142799 | 000 |