BrainTemp Neonate System (BTNeo System)
FDA 510(k) clearance DEN200042 · decided 2022-03-29
Clearance details
- K-number
- DEN200042
- Device name
- BrainTemp Neonate System (BTNeo System)
- Applicant
- Brain Temp, Inc.
- Decision
- Unknown
- Date received
- 2020-06-23
- Decision date
- 2022-03-29
- Days to decision
- 644 days
- Clearance type
- Direct
- Product code
- QSL
- Device class
- 2
- Regulation number
- 882.1565
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Bryn Mawr, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.