The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Infrared Fluorescence (irf) Imaging System.
| Device ID | K142310 |
| 510k Number | K142310 |
| Device Name: | Stryker Infrared Fluorescence (IRF) Imaging System |
| Classification | Confocal Optical Imaging |
| Applicant | Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 |
| Contact | Golnaz Moeini |
| Correspondent | Golnaz Moeini Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-08-19 |
| Decision Date | 2014-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327174359 | K142310 | 000 |
| 07613327174328 | K142310 | 000 |
| 07613327063912 | K142310 | 000 |
| 07613327063905 | K142310 | 000 |
| 07613327059373 | K142310 | 000 |
| 07613327059342 | K142310 | 000 |
| 07613327051674 | K142310 | 000 |
| 07613327051377 | K142310 | 000 |