510(k) K250818
- Device
- Nerveblox
- Applicant
- Smart Alfa Teknoloji San. Ve Tic. A.S.
- 510(k) number
- K250818
- Product code
- QRG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-15
- Date received
- 2025-03-18
- Regulation
- 868.1980
- Classification name
- Ultrasound Guided Nerve Block Assist
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Utku Kaya
- Address
- Universiteler Mah. Ihsan Dogramaci Blv. No:17-1 #109 Cankaya Ankara TR 06800 06800
FDA Registration Numbers#
- 3042158826