FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ExSpiron 1Xi
K Number: K173181
·
Decision Mar 16, 2018
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
4
Review Days
168
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Basic Information
- Device Name
- ExSpiron 1Xi
- K Number
- K173181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1850
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Respiratory Motion, Inc.
- Date Received
- September 29, 2017
- Decision Date
- March 16, 2018
- 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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