The following data is part of a premarket notification filed by Novadaq Technologies Ulc. (now A Part Of Stryker) with the FDA for Spy Elite Intraoperative Perfusion Assessment System.
| Device ID | K182907 |
| 510k Number | K182907 |
| Device Name: | SPY Elite Intraoperative Perfusion Assessment System |
| Classification | System, X-ray, Angiographic |
| 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 | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-10-17 |
| Decision Date | 2019-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20858701006265 | K182907 | 000 |