510(k) K934700

MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY by Tempo Technology, Inc. — Product Code OXO

K934700 is an FDA 510(k) premarket notification submitted by Tempo Technology, Inc. for the device "MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY". The FDA issued a decision of Substantially Equivalent on March 16, 1994. The device falls under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile), a Class II device regulated under 21 CFR 892.1650. Tempo Technology, Inc. has at least 2 other 510(k) clearances on record.