The following data is part of a premarket notification filed by Novadaq Technologies Ulc (now A Part Of Stryker) with the FDA for Spy-phi System With Spy-phi Fluorescence Assessment Software.
| Device ID | K202244 |
| 510k Number | K202244 |
| Device Name: | SPY-PHI System With SPY-PHI Fluorescence Assessment Software |
| Classification | Confocal Optical Imaging |
| Applicant | Novadaq Technologies ULC (now A Part Of Stryker) 8329 Eastlake Drive, Unit 101 Burnaby, CA V5a 4w2 |
| Contact | Agatha Szeliga |
| Correspondent | Agatha Szeliga Novadaq Technologies ULC (now A Part Of Stryker) 8329 Eastlake Drive, Unit 101 Burnaby, CA V5a 4w2 |
| Product Code | OWN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2020-08-10 |
| Decision Date | 2020-11-05 |