The following data is part of a premarket notification filed by Little Sparrows Technologies, Inc. with the FDA for Bili-hut.
| Device ID | K190899 |
| 510k Number | K190899 |
| Device Name: | Bili-hut |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | Little Sparrows Technologies, Inc. 176 Mystic Valley Parkway Winchester, MA 01890 |
| Contact | Erica Konston |
| Correspondent | Erica Konston Little Sparrows Technologies, Inc. 176 Mystic Valley Parkway Winchester, MA 01890 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-08 |
| Decision Date | 2019-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850019925876 | K190899 | 000 |
| 00850019925371 | K190899 | 000 |
| 00850019925364 | K190899 | 000 |
| 00850019925357 | K190899 | 000 |
| 00850019925098 | K190899 | 000 |
| 00850019925081 | K190899 | 000 |
| 00850019925074 | K190899 | 000 |
| 00850019925043 | K190899 | 000 |
| 00850019925036 | K190899 | 000 |
| 00810101280542 | K190899 | 000 |
| 00810101280504 | K190899 | 000 |
| 00810101280450 | K190899 | 000 |
| 00810101280443 | K190899 | 000 |
| 00810101280436 | K190899 | 000 |
| 00810101280412 | K190899 | 000 |
| 00810101280405 | K190899 | 000 |
| 00810101280054 | K190899 | 000 |
| 00810101280047 | K190899 | 000 |
| 00850019925388 | K190899 | 000 |
| 00850019925395 | K190899 | 000 |
| 00850019925401 | K190899 | 000 |
| 00850019925869 | K190899 | 000 |
| 00850019925753 | K190899 | 000 |
| 00850019925746 | K190899 | 000 |
| 00850019925722 | K190899 | 000 |
| 00850019925715 | K190899 | 000 |
| 00850019925555 | K190899 | 000 |
| 00850019925548 | K190899 | 000 |
| 00850019925524 | K190899 | 000 |
| 00850019925517 | K190899 | 000 |
| 00850019925500 | K190899 | 000 |
| 00850019925494 | K190899 | 000 |
| 00850019925487 | K190899 | 000 |
| 00850019925463 | K190899 | 000 |
| 00850019925449 | K190899 | 000 |
| 00850019925432 | K190899 | 000 |
| 00850019925425 | K190899 | 000 |
| 00850019925418 | K190899 | 000 |
| 00810101280023 | K190899 | 000 |