FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES
K Number: K091856
·
Decision Aug 7, 2009
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
82
Review Days
45
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Basic Information
- Device Name
- CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES
- K Number
- K091856
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Conmed Corporation
- Date Received
- June 23, 2009
- Decision Date
- August 7, 2009
- Product Code
- DRX
- 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
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