FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXSPIRON 1XI
K Number: K130170
·
Decision May 29, 2013
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
4
Review Days
125
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Basic Information
- Device Name
- EXSPIRON 1XI
- K Number
- K130170
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.1850
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Respiratory Motion, Inc.
- Date Received
- January 24, 2013
- Decision Date
- May 29, 2013
- Product Code
- BZK
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BZK | Spirometer, Monitoring (W/Wo Alarm) | FDA class 2 | Anesthesiology |
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