The following data is part of a premarket notification filed by Scholly Fiberoptic Gmbh with the FDA for Video Bronchoscope System.
Device ID | K141366 |
510k Number | K141366 |
Device Name: | VIDEO BRONCHOSCOPE SYSTEM |
Classification | Bronchoscope (flexible Or Rigid) |
Applicant | SCHOLLY FIBEROPTIC GMBH ROBERT-BOSCH-STR. 1-3 Denzlingen, DE D-79211 |
Contact | Sandra Baumann |
Correspondent | Sandra Baumann SCHOLLY FIBEROPTIC GMBH ROBERT-BOSCH-STR. 1-3 Denzlingen, DE D-79211 |
Product Code | EOQ |
CFR Regulation Number | 874.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-23 |
Decision Date | 2014-12-17 |
Summary: | summary |