FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING
K Number: K834088
·
Decision Dec 15, 1983
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
29
Applicant Total
4
Review Days
92
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Basic Information
- Device Name
- GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING
- K Number
- K834088
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2225
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Whs Products, Inc.
- Date Received
- September 14, 1983
- Decision Date
- December 15, 1983
- Product Code
- HEM
- 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 |
|---|---|---|---|
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | FDA class 2 | Obstetrics/Gynecology |
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