FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HIGH SPEED ROTATION STARTER SA-40
K Number: K920723
·
Decision Apr 27, 1992
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
39
Applicant Total
90
Review Days
69
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Basic Information
- Device Name
- HIGH SPEED ROTATION STARTER SA-40
- K Number
- K920723
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1760
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shimadzu Medical Systems
- Date Received
- February 18, 1992
- Decision Date
- April 27, 1992
- Product Code
- ITY
- 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 |
|---|---|---|---|
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | FDA class 1 | Radiology |
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| K071289 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | Jan 9, 2008 | Substantially Equivalent |
| K071291 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | Jan 9, 2008 | Substantially Equivalent |
| K061643 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | Jul 27, 2006 | Substantially Equivalent |
| K061637 | ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO | Jul 25, 2006 | Substantially Equivalent |
| K061641 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO | Jul 14, 2006 | Substantially Equivalent |
| K052500 | DAR-8000F | Oct 17, 2005 | Substantially Equivalent |
| K052076 | DAR-8000I | Sep 2, 2005 | Substantially Equivalent |
| K050510 | ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | Apr 1, 2005 | Substantially Equivalent |