The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corporation with the FDA for D Camera Controller.
Device ID | K211332 |
510k Number | K211332 |
Device Name: | D Camera Controller |
Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
Applicant | Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061 |
Contact | Michael Loiterman |
Correspondent | Michael Loiterman Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061 |
Product Code | FET |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-05-03 |
Decision Date | 2021-10-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04055207066188 | K211332 | 000 |