FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLADDERMANAGER PCI 5000 MODEL 1002
K Number: K982568
·
Decision Jan 25, 1999
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
16
Review Days
186
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Basic Information
- Device Name
- BLADDERMANAGER PCI 5000 MODEL 1002
- K Number
- K982568
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diagnostic Ultrasound Corp.
- Date Received
- July 23, 1998
- Decision Date
- January 25, 1999
- Product Code
- ITX
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
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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 |
| K963585 | BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000 | Oct 1, 1996 | Substantially Equivalent |
| K955840 | BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 | May 24, 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 |