FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇿 New Zealand
Gastric Alimetry System
K Number: K213924
·
Decision Jun 3, 2022
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
7
Applicant Total
5
Review Days
170
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Gastric Alimetry System
- K Number
- K213924
- 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
- December 15, 2021
- Decision Date
- June 3, 2022
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MYE), ordered by most recent decision date.
Gastric Alimetry
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Gastric Alimetry
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Gastric Alimetry System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Gastric Alimetry System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
G-Tech Wireless Patch System (WPS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology