FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Neteera 130H/131H Vital Sign Monitoring Sensor
K Number: K212143
·
Decision Sep 28, 2022
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
2
Review Days
446
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Basic Information
- Device Name
- Neteera 130H/131H Vital Sign Monitoring Sensor
- K Number
- K212143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neteera Technologies , Ltd.
- Date Received
- July 9, 2021
- Decision Date
- September 28, 2022
- 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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Other Clearances by Neteera Technologies , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K231733 | Neteera 130H-Plus Vital Sign Monitoring Sensor | Feb 9, 2024 | Substantially Equivalent |