FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
EsoCheck CCD Cell Collection Device
K Number: K183262
·
Decision Jun 21, 2019
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
29
Applicant Total
4
Review Days
210
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Basic Information
- Device Name
- EsoCheck CCD Cell Collection Device
- K Number
- K183262
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4710
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Lucid Diagnostics, Inc.
- Date Received
- November 23, 2018
- Decision Date
- June 21, 2019
- Product Code
- EOX
- Advisory Committee
- Ear, Nose, Throat
- 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 |
|---|---|---|---|
| EOX | Esophagoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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