FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Vital Sign Monitoring Sensor (Model :XK300)
K Number: K202464
·
Decision Apr 26, 2021
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
1
Review Days
242
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Basic Information
- Device Name
- Vital Sign Monitoring Sensor (Model :XK300)
- K Number
- K202464
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xandar Kardian, Inc.
- Date Received
- August 27, 2020
- Decision Date
- April 26, 2021
- Product Code
- DRT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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