FDA 510(k)
Substantially Equivalent
🇰🇷 South Korea
EKG-PLUS II SOFTWARE
K Number: K090895
·
Decision Aug 26, 2009
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
11
Review Days
149
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Basic Information
- Device Name
- EKG-PLUS II SOFTWARE
- K Number
- K090895
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bionet Co., Ltd.
- Date Received
- March 30, 2009
- Decision Date
- August 26, 2009
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
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