Product code KRC— Cardiovascular

FDA has cleared 11 devices under product code KRC between 1977 and 2004, filed by 10 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.

• 20041 clearance
• 19873 clearances
• 19842 clearances
• 19832 clearances
• 19811 clearance
• 19781 clearance
• 19771 clearance

• Circadian, Inc.2 clearances
• Sontra Medical, Inc.1 clearance
• Mg Medical Electronics1 clearance
• Marquette Electronics, Inc.1 clearance
• Lintronics Industries, Inc.1 clearance
• Gerard Medical Enterprises, Inc.1 clearance
• General Devices1 clearance
• E.B.S., Inc.1 clearance
• Delta Medical Industries1 clearance
• Aequitron Medical, Inc.1 clearance

• K023713 — SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000Sontra Medical, Inc.·2004-01-28
• K872370 — BIOMA 3500E.B.S., Inc.·1987-12-07
• K874155 — CIRCAMED MONITOR REMOTE START CONDUCTANCE METERCircadian, Inc.·1987-11-23
• K874327 — SKIN PREP ANALYZERMarquette Electronics, Inc.·1987-11-23
• K840358 — IMPEDANCE/8200 MONITOR-MODEL 8300Aequitron Medical, Inc.·1984-10-30
• K833619 — CONDUCTANCE METERCircadian, Inc.·1984-01-27
• K830823 — Z VIEW METER MODEL 300Lintronics Industries, Inc.·1983-05-18
• K830876 — PREP-CHECKGeneral Devices·1983-05-18
• K813358 — GERARD MEDICAL ELECTRODE TESTERGerard Medical Enterprises, Inc.·1981-12-29
• K780501 — ELECTRODE TESTERMg Medical Electronics·1978-05-19
• K771014 — TS-100 TEST SYSTEMDelta Medical Industries·1977-06-14