FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System
K Number: K170614
·
Decision Oct 19, 2017
Classifications
1
FEI Numbers
177
Registration Numbers
178
Same Product Code
506
Applicant Total
25
Review Days
232
Basic Information
- Device Name
- CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System
- K Number
- K170614
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- i-SENS, Inc.
- Date Received
- March 1, 2017
- Decision Date
- October 19, 2017
- Product Code
- NBW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | FDA class 2 | Clinical Chemistry |
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Other Clearances by i-SENS, Inc.
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|---|---|---|---|
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| K192859 | CareSens S Clear BT Blood Glucose Monitoring System | Jan 24, 2020 | Substantially Equivalent |
| K193590 | CareSens S Fit BT Blood Glucose Monitoring System | Jan 17, 2020 | Substantially Equivalent |
| K192220 | ReliOn Premier Classic Blood Glucose Monitoring System | Dec 13, 2019 | Substantially Equivalent |
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| K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System | Apr 13, 2018 | Substantially Equivalent |