FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST
K Number: K910212
·
Decision Jul 11, 1991
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
6
Applicant Total
3
Review Days
177
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Basic Information
- Device Name
- COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST
- K Number
- K910212
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Acoustic Imaging Technologies Corp.
- Date Received
- January 15, 1991
- Decision Date
- July 11, 1991
- Product Code
- JYO
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| JYO | Knife, Ear | FDA class 1 | Ear, Nose, Throat |
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