Product code HEI— Obstetrics/Gynecology

FDA has cleared 3 devices under product code HEI between 1991 and 2002, filed by 3 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.

• 20021 clearance
• 19921 clearance
• 19911 clearance

• Snowden-Pencer1 clearance
• M.D. Engineering, Inc.1 clearance
• Doctor'S Research Group, Inc.1 clearance

• K012003 — DRG REACTION CHAMBER/SAFETY TIPDoctor'S Research Group, Inc.·2002-02-12
• K920985 — SNOWDEN-PENCER IRRIGATION PUMPSnowden-Pencer·1992-06-09
• K910982 — INNERVISION IRRIGATION PUMPM.D. Engineering, Inc.·1991-08-26