FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Zsquare ENT-Flex Endoscope
K Number: K220004
·
Decision Jun 14, 2022
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
161
Applicant Total
1
Review Days
161
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Basic Information
- Device Name
- Zsquare ENT-Flex Endoscope
- K Number
- K220004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zsquare, Ltd.
- Date Received
- January 4, 2022
- Decision Date
- June 14, 2022
- Product Code
- EOB
- 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 |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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