FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EcoVue Sterile and Non-Sterile Ultrasound Gels
K Number: K181363
·
Decision Jun 13, 2018
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
33
Applicant Total
2
Review Days
21
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Basic Information
- Device Name
- EcoVue Sterile and Non-Sterile Ultrasound Gels
- K Number
- K181363
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- H R Pharmaceuticals, Inc.
- Date Received
- May 23, 2018
- Decision Date
- June 13, 2018
- Product Code
- MUI
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUI | Media, Coupling, Ultrasound | FDA class 2 | Radiology |
Similar 510(k) Clearances
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Other Clearances by H R Pharmaceuticals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K200556 | AquaFlate Pre-Filled Sterile Water Syringe 10mL | Mar 31, 2020 | Substantially Equivalent |