The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Evis Exera Bronchovideoscope, Olympus Xbf-160y3ac, Xbf-1t160y3ac,xbf-q160y2ac.
Device ID | K050220 |
510k Number | K050220 |
Device Name: | EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville, NY 11747 -9058 |
Contact | Laura Storms-tyler |
Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2005-01-31 |
Decision Date | 2005-02-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04953170340086 | K050220 | 000 |