The following data is part of a premarket notification filed by Novadaq Technologies, Inc. with the FDA for Pinpoint Endoscopic Fluorescence Imaging System.
| Device ID | K150956 |
| 510k Number | K150956 |
| Device Name: | PINPOINT Endoscopic Fluorescence Imaging System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NOVADAQ TECHNOLOGIES, INC. 8329 Eastlake Drive, Unit 101 Burnaby, CA V5a4w2 |
| Contact | Tim Verspagen |
| Correspondent | Tim Verspagen NOVADAQ TECHNOLOGIES, INC. 8329 Eastlake Drive, Unit 101 Burnaby, CA V5a4w2 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-04-09 |
| Decision Date | 2016-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858701006568 | K150956 | 000 |
| 00858701006551 | K150956 | 000 |