The following data is part of a premarket notification filed by International Biomedical with the FDA for Airborne Phototherapy Light.
Device ID | K160238 |
510k Number | K160238 |
Device Name: | Airborne Phototherapy Light |
Classification | Unit, Neonatal Phototherapy |
Applicant | INTERNATIONAL BIOMEDICAL 8206 CROSS PARK DR. Austin, TX 78754 |
Contact | Amy Pieper |
Correspondent | Amy Pieper INTERNATIONAL BIOMEDICAL 8206 CROSS PARK DR. Austin, TX 78754 |
Product Code | LBI |
CFR Regulation Number | 880.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-01 |
Decision Date | 2016-06-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00868406000075 | K160238 | 000 |