FDA 510(k)
Substantially Equivalent
🇯🇵 Japan
SDL-10 DIAGNOSTIC ULTRASOUND
K Number: K837314
·
Decision Apr 29, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
49
Review Days
38
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SDL-10 DIAGNOSTIC ULTRASOUND
- K Number
- K837314
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Shimadzu Corp.
- Date Received
- March 22, 1983
- Decision Date
- April 29, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
Other Clearances by Shimadzu Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K142341 | X-RAY TV SYSTEM SONIALVISION G4 | Mar 6, 2015 | Substantially Equivalent |
| K131075 | X-RAY TV SYSTEM SONIAL VISION G4 | Mar 28, 2014 | Substantially Equivalent |
| K101039 | SHIMADZU COLLIMATOR R-300 | Sep 20, 2010 | Substantially Equivalent |
| K101036 | SHIMADZU COLLIMATOR R-20J | Aug 26, 2010 | Substantially Equivalent |
| K090578 | SHIMADZU COLLIMATOR R-30H | Nov 6, 2009 | Substantially Equivalent |
| K090268 | SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION | Jun 30, 2009 | Substantially Equivalent |
| K080701 | SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION | May 14, 2008 | Substantially Equivalent |
| K072006 | DAR-9400F | Aug 31, 2007 | Substantially Equivalent |
| K071717 | GE OEC ALTITUDE | Jul 5, 2007 | Substantially Equivalent |
| K062360 | BRANSIST SAFIRE | Oct 5, 2006 | Substantially Equivalent |