510(k) K242346
K242346 is an FDA 510(k) premarket notification submitted by Natus Manufacturing Limited for the device "Grass® MR Conditional/CT Cup Electrodes". The FDA issued a decision of Substantially Equivalent on August 29, 2024. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Natus Manufacturing Limited has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2024
- Date Received
- August 7, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type