FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER
K Number: K011329
·
Decision Jul 26, 2002
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
11
Applicant Total
3
Review Days
451
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Basic Information
- Device Name
- ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER
- K Number
- K011329
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- E. Benson Hood Lab, Inc.
- Date Received
- May 1, 2001
- Decision Date
- July 26, 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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