FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000
K Number: K955840
·
Decision May 24, 1996
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
16
Review Days
150
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Basic Information
- Device Name
- BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000
- K Number
- K955840
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diagnostic Ultrasound Corp.
- Date Received
- December 26, 1995
- Decision Date
- May 24, 1996
- Product Code
- IYO
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Diagnostic Ultrasound Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K030763 | DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM | Mar 26, 2003 | Substantially Equivalent |
| K022153 | BLADDERSCAN BVI 6100 | Aug 15, 2002 | Substantially Equivalent |
| K982568 | BLADDERMANAGER PCI 5000 MODEL 1002 | Jan 25, 1999 | Substantially Equivalent |
| K963585 | BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000 | Oct 1, 1996 | Substantially Equivalent |
| K955942 | BLADDERSCAN BVI 5000 | Mar 15, 1996 | Substantially Equivalent |
| K920664 | DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION | Dec 23, 1993 | Substantially Equivalent |
| K915342 | UD 2000 VIDEO OPTION | Jun 10, 1992 | Substantially Equivalent |
| K915436 | BLADDERSCAN BVI 2500 | Mar 3, 1992 | Substantially Equivalent |
| K911166 | DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 | Aug 15, 1991 | Substantially Equivalent |
| K911125 | DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 | Aug 15, 1991 | Substantially Equivalent |