510(k) K974127
K974127 is an FDA 510(k) premarket notification submitted by Automata Instrumentation, Inc. for the device "HYDRA METER". The FDA issued a decision of Substantially Equivalent on December 19, 1997. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Automata Instrumentation, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 1997
- Date Received
- November 3, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Subsystem, Water Purification
- Device Class
- Class II
- Regulation Number
- 876.5665
- Review Panel
- GU
- Submission Type