The following data is part of a premarket notification filed by Vitalmetrics, Inc. with the FDA for Vital-vue Illumination, Suction & Irrigation Sys.
| Device ID | K883201 |
| 510k Number | K883201 |
| Device Name: | VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS |
| Classification | Illuminator, Fiberoptic, Surgical Field |
| Applicant | VITALMETRICS, INC. 11339 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Contact | Jeffrey Castleberry |
| Correspondent | Jeffrey Castleberry VITALMETRICS, INC. 11339 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Product Code | HBI |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-28 |
| Decision Date | 1988-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521176109 | K883201 | 000 |
| 20884521176116 | K883201 | 000 |
| 20884521176093 | K883201 | 000 |
| 20884521176086 | K883201 | 000 |
| 20884521176079 | K883201 | 000 |
| 10884521042520 | K883201 | 000 |
| 10884521042490 | K883201 | 000 |
| 10884521042483 | K883201 | 000 |
| 10884521042445 | K883201 | 000 |