FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
METIC- Airway Balloon Catheter
K Number: K231818
·
Decision Nov 15, 2023
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
32
Applicant Total
1
Review Days
147
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Basic Information
- Device Name
- METIC- Airway Balloon Catheter
- K Number
- K231818
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- M/S Meril Life Sciences Pvt. , Ltd.
- Date Received
- June 21, 2023
- Decision Date
- November 15, 2023
- Product Code
- KTI
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| KTI | Bronchoscope Accessory | FDA class 2 | Ear, Nose, Throat |
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