FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Regulora
K Number: K211463
·
Decision Nov 24, 2021
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
1
Review Days
197
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Basic Information
- Device Name
- Regulora
- K Number
- K211463
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5960
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Metame Health, Inc.
- Date Received
- May 11, 2021
- Decision Date
- November 24, 2021
- Product Code
- QMY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QMY | Computerized Behavioral Therapy Device For Treating Symptoms | FDA class 2 | Gastroenterology, Urology |
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