FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMBU BLUE SENSOR NEO AND NEO X
K Number: K053550
·
Decision Oct 25, 2006
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
15
Review Days
309
Basic Information
- Device Name
- AMBU BLUE SENSOR NEO AND NEO X
- K Number
- K053550
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AMBU A/S
- Date Received
- December 20, 2005
- Decision Date
- October 25, 2006
- 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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Other Clearances by AMBU A/S
| K Number | Device Name | ||
|---|---|---|---|
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| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator | Aug 29, 2016 | Substantially Equivalent |
| K160766 | Ambu USR, Ambu M | Aug 17, 2016 | Substantially Equivalent |
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| K110962 | AMBU ASCOPE 2 | Nov 18, 2011 | Substantially Equivalent |
| K102824 | AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC | Jan 28, 2011 | Substantially Equivalent |
| K100129 | AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X | Jun 11, 2010 | Substantially Equivalent |
| K093186 | AMBU ASCOPE AND MONITOR | Apr 16, 2010 | Substantially Equivalent |
| K093825 | AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE | Jan 13, 2010 | Substantially Equivalent |
| K071186 | MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE | Jul 30, 2007 | Substantially Equivalent |