510(k) K230148
K230148 is an FDA 510(k) premarket notification submitted by Dormotech Medical, Ltd. for the device "Vlab". The FDA issued a decision of Substantially Equivalent on October 11, 2023. The device falls under product code GWL (Amplifier, Physiological Signal), a Class II device regulated under 21 CFR 882.1835. Dormotech Medical, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 11, 2023
- Date Received
- January 19, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amplifier, Physiological Signal
- Device Class
- Class II
- Regulation Number
- 882.1835
- Review Panel
- NE
- Submission Type