The following data is part of a premarket notification filed by I.s.g. Technologies, Inc. with the FDA for Allegro Viewing Wand.
Device ID | K911783 |
510k Number | K911783 |
Device Name: | ALLEGRO VIEWING WAND |
Classification | System, Image Processing, Radiological |
Applicant | I.S.G. TECHNOLOGIES, INC. 6509 AIRPORT ROAD Mississauga, Ontario, CA L4v 1s7 |
Contact | Bruce Leggett |
Correspondent | Bruce Leggett I.S.G. TECHNOLOGIES, INC. 6509 AIRPORT ROAD Mississauga, Ontario, CA L4v 1s7 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-22 |
Decision Date | 1994-04-07 |