The following data is part of a premarket notification filed by Bio-med Usa with the FDA for Bt-400.
| Device ID | K142332 |
| 510k Number | K142332 |
| Device Name: | BT-400 |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | Bio-Med USA 27 New England Drive Ramsey, NJ 07446 |
| Contact | Young Chi |
| Correspondent | Young Chi Bio-Med USA 27 New England Drive Ramsey, NJ 07446 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-20 |
| Decision Date | 2015-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887529000189 | K142332 | 000 |
| 10887529000110 | K142332 | 000 |