FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM
K Number: K073265
·
Decision Mar 14, 2008
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
14
Applicant Total
2
Review Days
115
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Basic Information
- Device Name
- APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM
- K Number
- K073265
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3080
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apieron, Inc.
- Date Received
- November 20, 2007
- Decision Date
- March 14, 2008
- 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 | ||
|---|---|---|---|
| K083617 | APIERON INSIGHT ENO SYSTEM | Jan 27, 2009 | Substantially Equivalent |