The following data is part of a premarket notification filed by International Biomedical with the FDA for Nuborne Infant Warmer.
| Device ID | K173516 |
| 510k Number | K173516 |
| Device Name: | NuBorne Infant Warmer |
| Classification | Warmer, Infant Radiant |
| Applicant | International Biomedical 8206 Cross Park Drive Austin, TX 78754 |
| Contact | Amy Pieper |
| Correspondent | Amy Pieper International Biomedical 8206 Cross Park Drive Austin, TX 78754 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-14 |
| Decision Date | 2018-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865648000313 | K173516 | 000 |