SpiroThor— 510(k) K150137
Substantially EquivalentCohero Health, LLC
FDA 510(k) clearance K150137 for SpiroThor, Substantially Equivalent on 2015-05-27. Applicant: Cohero Health, LLC. Device class: 2.
Clearance details
- Applicant
- Cohero Health, LLC
- 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
- Traditional
- Location
- New York, NY, US
Recent devices under product code BZG
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