FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
BGM014 Blood Glucose Monitoring System
K Number: K182992
·
Decision Nov 28, 2018
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
35
Review Days
30
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Basic Information
- Device Name
- BGM014 Blood Glucose Monitoring System
- K Number
- K182992
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apex BioTechnology Corp.
- Date Received
- October 29, 2018
- Decision Date
- November 28, 2018
- 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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|---|---|---|---|
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| K202534 | MTM301 Blood Glucose and Ketone Monitoring System | Apr 6, 2022 | Substantially Equivalent |
| K213887 | GAL-1A Plus Blood Glucose Monitoring System | Mar 29, 2022 | Substantially Equivalent |
| K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring System | Oct 15, 2021 | Substantially Equivalent |
| K202885 | GlucoSure HT Plus Blood Glucose Monitoring System | Sep 15, 2021 | Substantially Equivalent |
| K182593 | KET-1 Blood Ketone Monitoring System | Dec 18, 2018 | Substantially Equivalent |
| K170267 | BGM009 Plus Blood Glucose Monitoring System | Mar 9, 2017 | Substantially Equivalent |