FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
AI100 with Shonit
K Number: K221309
·
Decision Sep 19, 2023
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
34
Applicant Total
1
Review Days
502
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Basic Information
- Device Name
- AI100 with Shonit
- K Number
- K221309
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5260
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sigtuple Technologies Pvt. , Ltd.
- Date Received
- May 5, 2022
- Decision Date
- September 19, 2023
- Product Code
- JOY
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JOY | Device, Automated Cell-Locating | FDA class 2 | Hematology |
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