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 |