The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympic Bili-lite.
Device ID | K940996 |
510k Number | K940996 |
Device Name: | OLYMPIC BILI-LITE |
Classification | Unit, Neonatal Phototherapy |
Applicant | OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
Contact | Joseph P Stefanile |
Correspondent | Joseph P Stefanile OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
Product Code | LBI |
CFR Regulation Number | 880.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-04 |
Decision Date | 1994-09-16 |