FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RHINOSTREAM RHINOMANOMETER MODULE
K Number: K022311
·
Decision Oct 4, 2002
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
11
Applicant Total
2
Review Days
79
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Basic Information
- Device Name
- RHINOSTREAM RHINOMANOMETER MODULE
- K Number
- K022311
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rhino Metrics A/S
- Date Received
- July 17, 2002
- Decision Date
- October 4, 2002
- Product Code
- BXQ
- 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 |
|---|---|---|---|
| BXQ | Rhinoanemometer (Measurement Of Nasal Decongestion) | FDA class 2 | Anesthesiology |
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Other Clearances by Rhino Metrics A/S
| K Number | Device Name | ||
|---|---|---|---|
| K000406 | RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE | Apr 17, 2000 | Substantially Equivalent |