FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
HD-550 Video Endoscope System
K Number: K222020
·
Decision Sep 8, 2022
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
8
Applicant Total
12
Review Days
62
Basic Information
- Device Name
- HD-550 Video Endoscope System
- K Number
- K222020
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sonoscape Medical Corp.
- Date Received
- July 8, 2022
- Decision Date
- September 8, 2022
- Product Code
- NWB
- 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 |
|---|---|---|---|
| NWB | Endoscope, Accessories, Narrow Band Spectrum | FDA class 2 | Gastroenterology, Urology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K221089 | P12 Elite Series Digital Color Doppler Ultrasound System | Sep 15, 2022 | Substantially Equivalent |
| K221140 | P20 Elite Series Digital Color Doppler Ultrasound System | Sep 13, 2022 | Substantially Equivalent |
| K201059 | S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System | Jul 30, 2020 | Substantially Equivalent |
| K182648 | X5 Series Digital Color Doppler Ultrasound System | Jan 29, 2019 | Substantially Equivalent |
| K173921 | HD-500 Video Endoscope System | Sep 5, 2018 | Substantially Equivalent |
| K172993 | P20 Series Digital Color Doppler Ultrasound System | Dec 5, 2017 | Substantially Equivalent |
| K173058 | P10 Series Digital Color Doppler Ultrasound System | Dec 1, 2017 | Substantially Equivalent |