GoSpiro— 510(k) K202837
Substantially EquivalentMonitored Therapeutics, Inc.
FDA 510(k) clearance K202837 for GoSpiro, Substantially Equivalent on 2020-12-04. Applicant: Monitored Therapeutics, Inc.. Device class: 2.
Clearance details
- Applicant
- Monitored Therapeutics, Inc.
- Product code
- Code BZG
- Device class
- Class 2
- Regulation
- 21 CFR 868.1840
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Dublin, OH, US
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