The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Neonatal Phototherapy Unit.
Device ID | K802702 |
510k Number | K802702 |
Device Name: | NEONATAL PHOTOTHERAPY UNIT |
Classification | Unit, Neonatal Phototherapy |
Applicant | OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LBI |
CFR Regulation Number | 880.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-03 |
Decision Date | 1980-12-10 |