FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APIERON INSIGHT ENO SYSTEM
K Number: K083617
·
Decision Jan 27, 2009
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
14
Applicant Total
2
Review Days
50
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Basic Information
- Device Name
- APIERON INSIGHT ENO SYSTEM
- K Number
- K083617
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3080
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apieron, Inc.
- Date Received
- December 8, 2008
- Decision Date
- January 27, 2009
- Product Code
- MXA
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| MXA | System, Test, Breath Nitric Oxide | FDA class 2 | Clinical Toxicology |
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Other Clearances by Apieron, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K073265 | APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM | Mar 14, 2008 | Substantially Equivalent |