FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URINARY DRAINAGE BAG
K Number: K934142
·
Decision May 17, 1994
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
8
Applicant Total
2
Review Days
265
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Basic Information
- Device Name
- URINARY DRAINAGE BAG
- K Number
- K934142
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1800
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Key Medical Services, Inc.
- Date Received
- August 25, 1993
- Decision Date
- May 17, 1994
- Product Code
- EXR
- 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 |
|---|---|---|---|
| EXR | Urinometer, Mechanical | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EXR), ordered by most recent decision date.
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Other Clearances by Key Medical Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951597 | URINARY DRAINAGE BAG | Aug 4, 1995 | Substantially Equivalent |