The following data is part of a premarket notification filed by Terarecon, Inc. with the FDA for Aquariusnet Server.
Device ID | K012086 |
510k Number | K012086 |
Device Name: | AQUARIUSNET SERVER |
Classification | System, Image Processing, Radiological |
Applicant | TERARECON, INC. 200 GREGORY LN. SUITE C-100 Pleasent Hill, CA 94523 -3389 |
Contact | David W Schlerf |
Correspondent | David W Schlerf TERARECON, INC. 200 GREGORY LN. SUITE C-100 Pleasent Hill, CA 94523 -3389 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-03 |
Decision Date | 2001-09-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
INTUITION7 | K012086 | 000 |
INTUITION3 | K012086 | 000 |
INTUITION2 | K012086 | 000 |
INTUITION9 | K012086 | 000 |
INTUITION12 | K012086 | 000 |