510(k) K123255
K123255 is an FDA 510(k) premarket notification submitted by G.Tec Medical Engineering GmbH for the device "g.HIamp". The FDA issued a decision of Substantially Equivalent on December 20, 2012. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. G.Tec Medical Engineering GmbH has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2012
- Date Received
- October 18, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Amplifier, Physiological Signal
- Device Class
- Class II
- Regulation Number
- 882.1835
- Review Panel
- NE
- Submission Type