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 |