The following data is part of a premarket notification filed by Bionix Development Corp. with the FDA for Little Angels Swaddling Blanket.
| Device ID | K123411 |
| 510k Number | K123411 |
| Device Name: | LITTLE ANGELS SWADDLING BLANKET |
| Classification | Blanket, Neonatal Phototherapy |
| Applicant | BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. Toledo, OH 43612 |
| Contact | James Huttner |
| Correspondent | James Huttner BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. Toledo, OH 43612 |
| Product Code | PDH |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-05 |
| Decision Date | 2013-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859911004368 | K123411 | 000 |
| 00859911004351 | K123411 | 000 |
| 00859911004283 | K123411 | 000 |
| 00859911004276 | K123411 | 000 |
| 08599110040126 | K123411 | 000 |
| 08599110040119 | K123411 | 000 |