FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
K Number: K003804
·
Decision Aug 30, 2001
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
1
Review Days
265
Basic Information
- Device Name
- SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801
- K Number
- K003804
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NIKO MEDICAL PRODUCTS
- Date Received
- December 8, 2000
- Decision Date
- August 30, 2001
- 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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