FDA 510(k)
FDA class 2
Unknown
🇮🇪 Ireland
Innovo
K Number: DEN170049
·
Decision Nov 6, 2018
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
4
Applicant Total
32
Review Days
414
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Basic Information
- Device Name
- Innovo
- K Number
- DEN170049
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 876.5330
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Applicant
- Bio-Medical Research, Ltd.
- Date Received
- September 18, 2017
- Decision Date
- November 6, 2018
- Product Code
- QAJ
- 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 |
|---|---|---|---|
| QAJ | Cutaneous Electrode Stimulator For Urinary Incontinence | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QAJ), ordered by most recent decision date.
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ELITONE Urge Urinary Incontinence Device
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INNOVO
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Elitone Device
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