SoundBite Console, SoundBite Active Wire 18— 510(k) K192211
Substantially EquivalentSoundbite Medical Solution, Inc.
FDA 510(k) clearance K192211 for SoundBite Console, SoundBite Active Wire 18, Substantially Equivalent on 2020-01-17. Applicant: Soundbite Medical Solution, Inc..
Clearance details
- Applicant
- Soundbite Medical Solution, Inc.
- Product code
- Code PDU
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montreal, CA
Adverse events under product code PDU
product code PDU- Malfunction
- 793
- Total
- 793
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.