Regulora— 510(k) K211463
Substantially EquivalentMetame Health, Inc.
FDA 510(k) clearance K211463 for Regulora, Substantially Equivalent on 2021-11-24. Applicant: Metame Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Metame Health, Inc.
- Product code
- Code QMY
- Device class
- Class 2
- Regulation
- 21 CFR 876.5960
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Recent devices under product code QMY
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