FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇿 New Zealand
SMARTTRACK SYSTEM
K Number: K091803
·
Decision Oct 9, 2009
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
507
Applicant Total
2
Review Days
115
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Basic Information
- Device Name
- SMARTTRACK SYSTEM
- K Number
- K091803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5630
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nexus6, Ltd.
- Date Received
- June 16, 2009
- Decision Date
- October 9, 2009
- Product Code
- CAF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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Other Clearances by Nexus6, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K133951 | SMARTTOUCH | Apr 25, 2014 | Substantially Equivalent |