FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
K Number: K100129
·
Decision Jun 11, 2010
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
38
Review Days
143
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Basic Information
- Device Name
- AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
- K Number
- K100129
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ambu A/S
- Date Received
- January 19, 2010
- Decision Date
- June 11, 2010
- 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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