FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUGROS HYSTEROMETER
K Number: K831224
·
Decision Oct 28, 1983
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
9
Applicant Total
5
Review Days
196
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Basic Information
- Device Name
- AUGROS HYSTEROMETER
- K Number
- K831224
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Axcan Scientific Corp.
- Date Received
- April 15, 1983
- Decision Date
- October 28, 1983
- Product Code
- HHM
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HHM | Sound, Uterine | FDA class 1 | Obstetrics/Gynecology |
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