Product code IYM— Obstetrics/Gynecology

FDA has cleared 8 devices under product code IYM between 1976 and 1986, filed by 8 applicant companies. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.

• 19862 clearances
• 19821 clearance
• 19812 clearances
• 19802 clearances
• 19761 clearance

• Orthion Corp.1 clearance
• Jeol1 clearance
• Hospital Financial Corp.1 clearance
• Honeywell, Inc.1 clearance
• Gst Laboratories of Ca, Inc.1 clearance
• Flir Medical Systems1 clearance
• Dorex, Inc.1 clearance
• C.D. Regelin & Associates, Inc.1 clearance

• K863736 — FMS MODEL 110Flir Medical Systems·1986-12-29
• K852950 — VISITHERMC.D. Regelin & Associates, Inc.·1986-02-07
• K823041 — JEOL MODEL #JTG-500MJeol·1982-11-24
• K812799 — DCATSDorex, Inc.·1981-10-20
• K812701 — ORTHO-THERM INFRARED SENSOROrthion Corp.·1981-10-13
• K801553 — THERMOCOMPHospital Financial Corp.·1980-10-31
• K800491 — GRAPHIC STRESS TELETHERMOMETRYGst Laboratories of Ca, Inc.·1980-03-04
• K760999 — THERMOGRAPH, MEDICALHoneywell, Inc.·1976-11-19