510(k) K982754

EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC) by A.Stein - Regulatory Affairs Consulting — Product Code FWF

K982754 is an FDA 510(k) premarket notification submitted by A.Stein - Regulatory Affairs Consulting for the device "EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)". The FDA issued a decision of Substantially Equivalent on January 8, 1999. The device falls under product code FWF (Camera, Television, Endoscopic, Without Audio), a Class I device regulated under 21 CFR 878.4160. A.Stein - Regulatory Affairs Consulting has at least 4 other 510(k) clearances on record.