Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford— 510(k) K163292
Substantially EquivalentSpectra Medical Devices
FDA 510(k) clearance K163292 for Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford, Substantially Equivalent on 2017-09-08. Applicant: Spectra Medical Devices. Device class: 2.
Clearance details
- Applicant
- Spectra Medical Devices
- Product code
- Code BSP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, MA, US
Recent devices under product code BSP
view allMore clearances from Spectra Medical Devices
view allAdverse events under product code BSP
product code BSP- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.