The following data is part of a premarket notification filed by Novadaq Technologies, Inc. with the FDA for Spy Intra-operative Imaging System.
Device ID | K100371 |
510k Number | K100371 |
Device Name: | SPY INTRA-OPERATIVE IMAGING SYSTEM |
Classification | System, X-ray, Angiographic |
Applicant | NOVADAQ TECHNOLOGIES, INC. 2585 SKYMARK AVENUE, STE. 306 Mississauga, Ontario, CA L4w 4l5 |
Contact | Dana Nohynek |
Correspondent | Dana Nohynek NOVADAQ TECHNOLOGIES, INC. 2585 SKYMARK AVENUE, STE. 306 Mississauga, Ontario, CA L4w 4l5 |
Product Code | IZI |
CFR Regulation Number | 892.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2010-02-12 |
Decision Date | 2011-02-04 |
Summary: | summary |