510(k) K981294
K981294 is an FDA 510(k) premarket notification submitted by Automata Instrumentation, Inc. for the device "ODYSSEY INSTRUMENTATION SYSTEM". The FDA issued a decision of Substantially Equivalent on July 8, 1998. The device falls under product code FIZ (Meter, Conductivity, Non-Remote), a Class II device regulated under 21 CFR 876.5820. Automata Instrumentation, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 1998
- Date Received
- April 9, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Meter, Conductivity, Non-Remote
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type