Product code DYC— Cardiovascular

FDA has cleared 4 devices under product code DYC between 1981 and 2003, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20031 clearance
• 19901 clearance
• 19831 clearance
• 19811 clearance

• Ortivus AB1 clearance
• Odam1 clearance
• Medical Graphics Corp.1 clearance
• Elmed, Inc.1 clearance

• K023414 — MIDA ALGORITHM REV. BOrtivus AB·2003-12-05
• K896396 — MIDA SYSTEM, MODELS 1000/1100Medical Graphics Corp.·1990-01-18
• K823934 — CARIEL F12Odam·1983-12-16
• K810529 — DIRECT WRITING VECTORCARDIOGRAPHElmed, Inc.·1981-04-23