FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLADDERSCAN BVI 2500
K Number: K915436
·
Decision Mar 3, 1992
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
16
Review Days
90
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Basic Information
- Device Name
- BLADDERSCAN BVI 2500
- K Number
- K915436
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diagnostic Ultrasound Corp.
- Date Received
- December 4, 1991
- Decision Date
- March 3, 1992
- 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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| 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 |
| K911166 | DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 | Aug 15, 1991 | Substantially Equivalent |
| K911125 | DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 | Aug 15, 1991 | Substantially Equivalent |