Searching for Titronics R&D's 510(k) might not be easy, so here is some help.
Titronics R&D has had their 510(k) for 12 years now, and it is archived in the Center for Devices and Radiological Health. The 510(k)'s in the past 8 or so years are easy to access. For older 510(k)'s (such as Titronics R&D's) you must download them in 5 year goupings, search and attain the 510(k) number, then search for it on the FDA website. Titronics submitted their 510(k) in 1997 and received their approval for marketing the Tytron on 02/03/1998. A link to the 510(k) is
www.accessdata.fda.gov/scripts/cdrh/cfdo...MN/pmn.cfm?ID=114530 A summary of the 510(k) is accesible here as well.
Best Regards,
Leonard (Leo) Smith
Titronics R&D
400 Stephans St. Suite D
Tiffin, IA 52340
1-800-705-2307
319-545-7377
