The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Evis Exera Bronchofibervideoscope Olympus Bf Type Xp160f, Its Accessories And Ancillary Equipment.
Device ID | K033225 |
510k Number | K033225 |
Device Name: | EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Contact | Tina Steffanie-oak |
Correspondent | Ned E 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 | 2003-10-06 |
Decision Date | 2003-10-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04953170340116 | K033225 | 000 |
04953170340093 | K033225 | 000 |
04953170340048 | K033225 | 000 |
04953170289064 | K033225 | 000 |
04953170289033 | K033225 | 000 |