FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇿 New Zealand
Gastric Alimetry
K Number: K240946
·
Decision Jul 3, 2024
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
7
Applicant Total
5
Review Days
89
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Basic Information
- Device Name
- Gastric Alimetry
- K Number
- K240946
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1735
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alimetry , Ltd.
- Date Received
- April 5, 2024
- Decision Date
- July 3, 2024
- Product Code
- MYE
- 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 |
|---|---|---|---|
| MYE | System, Electrogastrography (Egg) | FDA class 2 | Gastroenterology, Urology |
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