FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WesperO2
K Number: K213515
·
Decision Jun 10, 2022
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
4
Review Days
220
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Basic Information
- Device Name
- WesperO2
- K Number
- K213515
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wesper, Inc.
- Date Received
- November 2, 2021
- Decision Date
- June 10, 2022
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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