GoSpiro
FDA 510(k) clearance K202837 · decided 2020-12-04
Clearance details
- K-number
- K202837
- Device name
- GoSpiro
- Applicant
- Monitored Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-25
- Decision date
- 2020-12-04
- Days to decision
- 70 days
- Clearance type
- Special
- Product code
- BZG
- Device class
- 2
- Regulation number
- 868.1840
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Dublin, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.