The following data is part of a premarket notification filed by Novadaq Technologies, Inc. with the FDA for Spy Intra-operative Imaging System: Sp2000.
Device ID | K042961 |
510k Number | K042961 |
Device Name: | SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000 |
Classification | System, X-ray, Angiographic |
Applicant | NOVADAQ TECHNOLOGIES, INC. 2585 SKYMARK AVE., STE: 306 Mississauga, Ontario, CA L4w 4l5 |
Contact | Allison Manners |
Correspondent | Allison Manners NOVADAQ TECHNOLOGIES, INC. 2585 SKYMARK AVE., 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 | No |
Date Received | 2004-10-27 |
Decision Date | 2005-01-19 |
Summary: | summary |