FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MCT MEDICAL BROWNE UROSCAN URODYNAMIC
K Number: K880504
·
Decision Jun 17, 1988
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
15
Applicant Total
3
Review Days
133
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Basic Information
- Device Name
- MCT MEDICAL BROWNE UROSCAN URODYNAMIC
- K Number
- K880504
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1800
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Mct Medical, Inc.
- Date Received
- February 5, 1988
- Decision Date
- June 17, 1988
- Product Code
- EXY
- 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 |
|---|---|---|---|
| EXY | Uroflowmeter | FDA class 2 | Gastroenterology, Urology |
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