510(k) K936273

STEREO OPSIS CAMERA SYSTEM 3-D DISTAL CAM AND 3-D DISTAL CAM 360 by Baxter Healthcare Corp — Product Code HET

K936273 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "STEREO OPSIS CAMERA SYSTEM 3-D DISTAL CAM AND 3-D DISTAL CAM 360". The FDA issued a decision of Substantially Equivalent on Jan 6, 1995. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Baxter Healthcare Corp has 507 other 510(k) clearances on record.