FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM
K Number: K082521
·
Decision Jan 16, 2009
Classifications
1
FEI Numbers
168
Registration Numbers
169
Same Product Code
507
Applicant Total
49
Review Days
136
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Basic Information
- Device Name
- EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM
- K Number
- K082521
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Card Guard Scientific Survival , Ltd.
- Date Received
- September 2, 2008
- Decision Date
- January 16, 2009
- 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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| K061428 | PMP4 APPLICATION | Oct 16, 2006 | Substantially Equivalent |
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