FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE
K Number: K875119
·
Decision Mar 2, 1988
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
4
Applicant Total
4
Review Days
78
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Basic Information
- Device Name
- BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE
- K Number
- K875119
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Advanced Diagnostic Medical Systems, Inc.
- Date Received
- December 15, 1987
- Decision Date
- March 2, 1988
- Product Code
- FCI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FCI | Punch, Biopsy | FDA class 2 | Gastroenterology, Urology |
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