JAF — Monitor, Ultrasonic, Nonfetal Class II
FDA product code JAF covers "Monitor, Ultrasonic, Nonfetal", a Class II medical device regulated under 21 CFR 892.1540. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JAF
- Device Class
- Class II
- Regulation Number
- 892.1540
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242487 | laminar digital health | Laminar P1 (LDH-HW-001) | December 13, 2024 |
| K141657 | thd | THD REVOLUTION | February 24, 2015 |
| K110628 | newman medical | SIMPLEABI | May 12, 2011 |
| K093393 | summit doppler systems | LIFEDOP MODEL 300ABI | December 24, 2009 |
| K090009 | thd | THD SLIDE ONE | January 28, 2009 |
| K081429 | thd | THD SLIDE | July 30, 2008 |
| K070815 | g.f | THD | June 20, 2007 |
| K063600 | summit doppler systems | VISTA AVS | December 19, 2006 |
| K060064 | odvi | STETHOFLUX | April 10, 2006 |
| K052067 | multigon industries | DOPPLER GUIDED PROCTOSCOPE, MODEL 500H | August 29, 2005 |
| K010521 | nicolet biomedical | NICOLET VERSALAB | March 9, 2001 |
| K982635 | nicolet biomedical | CAREDOP II | August 7, 1998 |
| K973336 | imex medical systems | IMEX STETHODOP | February 5, 1998 |
| K973857 | biomedix | FLOSTAT VASCULAR REPORT GENERATOR (VRG) | December 29, 1997 |
| K973644 | biomedix | FLOSTAT VASCULAR LAB | December 23, 1997 |
| K943338 | biosensor | BIOSENSOR BIDOP VASCULAR TEST SYSTEM | April 12, 1996 |
| K943200 | advance medical device | FLOSCOPE SUPER VASCULAR LAB | November 21, 1995 |
| K944196 | imex medical systems | IMWXDOP IR | May 12, 1995 |
| K935427 | r and d batteries | R AND D BATTERIES | October 21, 1994 |
| K942441 | imex medical systems | IMEXDOP CT+ | August 23, 1994 |