The following data is part of a premarket notification filed by Carefusion 2200 with the FDA for Enview (tm).
Device ID | K102179 |
510k Number | K102179 |
Device Name: | ENVIEW (TM) |
Classification | Endoscope Holder |
Applicant | CAREFUSION 2200 6215 FERRIS SQUARE, SUITE #100 San Diego, CA 92121 |
Contact | Patricia A Ayers |
Correspondent | Patricia A Ayers CAREFUSION 2200 6215 FERRIS SQUARE, SUITE #100 San Diego, CA 92121 |
Product Code | OCV |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-03 |
Decision Date | 2010-12-02 |
Summary: | summary |