SoundBite Console, SoundBite Active Wire 18
FDA 510(k) clearance K192211 · decided 2020-01-17
Clearance details
- K-number
- K192211
- Device name
- SoundBite Console, SoundBite Active Wire 18
- Applicant
- Soundbite Medical Solution, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-08-14
- Decision date
- 2020-01-17
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- PDU
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Montreal, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.