FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PACEART OPTIMA SYSTEM SOFTWARE
K Number: K110693
·
Decision Jun 8, 2011
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
209
Review Days
89
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Basic Information
- Device Name
- PACEART OPTIMA SYSTEM SOFTWARE
- K Number
- K110693
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3640
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- March 11, 2011
- Decision Date
- June 8, 2011
- Product Code
- KRE
- 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 |
|---|---|---|---|
| KRE | Analyzer, Pacemaker Generator Function, Indirect | FDA class 2 | Cardiovascular |
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