FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BARD UROTRACK II MONITORING
K Number: K924436
·
Decision Mar 15, 1994
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
181
Applicant Total
645
Review Days
560
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Basic Information
- Device Name
- BARD UROTRACK II MONITORING
- K Number
- K924436
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- C.R. Bard, Inc.
- Date Received
- September 1, 1992
- Decision Date
- March 15, 1994
- Product Code
- KOC
- 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 |
|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | FDA class 2 | Gastroenterology, Urology |
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