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 |