The following data is part of a premarket notification filed by Automata Instrumentation, Inc. with the FDA for Odyssey Instrumentation System.
Device ID | K981294 |
510k Number | K981294 |
Device Name: | ODYSSEY INSTRUMENTATION SYSTEM |
Classification | Meter, Conductivity, Non-remote |
Applicant | AUTOMATA INSTRUMENTATION, INC. 15600 NORTH 78TH ST. Scottsdale, AZ 85260 -1735 |
Contact | Linda V Masano |
Correspondent | Linda V Masano AUTOMATA INSTRUMENTATION, INC. 15600 NORTH 78TH ST. Scottsdale, AZ 85260 -1735 |
Product Code | FIZ |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-04-09 |
Decision Date | 1998-07-08 |