Product code HME— Ophthalmic

FDA has cleared 16 devices under product code HME between 1978 and 1993, filed by 13 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19931 clearance
• 19921 clearance
• 19891 clearance
• 19871 clearance
• 19864 clearances
• 19854 clearances
• 19842 clearances
• 19801 clearance
• 19781 clearance

• F. & F. Koenigkramer3 clearances
• Koken Mfg Company, Inc.2 clearances
• Woodlyn, Inc.1 clearance
• Vision Health Technology1 clearance
• Techna Vision1 clearance
• Surgical Mechanical Research, Inc.1 clearance
• Storz Instrument Co.1 clearance
• Sds Dental, Inc.1 clearance
• Reliance Medical Products, Inc.1 clearance
• Marco Ophthalmic, Inc.1 clearance

• K930449 — MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIRMarco Ophthalmic, Inc.·1993-07-06
• K914416 — BREATH-EASY, MODIFICATIONIcor AB·1992-06-23
• K894018 — RELIANCE(R) 6200 EXAMINATION CHAIRReliance Medical Products, Inc.·1989-09-12
• K870112 — STORZ ENT/OPHTHALMIC MAXI CHAIRStorz Instrument Co.·1987-02-12
• K864494 — MODEL 6500 OPTHALMIC CHAIRKoken Mfg Company, Inc.·1986-12-15
• K864574 — MAC 150E OPTHALMIC CHAIRKoken Mfg Company, Inc.·1986-12-15
• K863728 — THE ERGOSYSTEM CHAIRCharles D. Bell, Inc.·1986-10-31
• K863008 — -OM WEST 2000 GNATUS CHAIRSds Dental, Inc.·1986-09-24
• K853743 — TECHNA VISION, INC. ELECTRIC CHAIRTechna Vision·1985-10-17
• K853149 — RELIANCE 1000, RELIANCE 1500, RELIANCE 2000F. & F. Koenigkramer·1985-09-05
• K853150 — RELIANCE 6100F. & F. Koenigkramer·1985-09-05
• K853151 — RELIANCE 5000F. & F. Koenigkramer·1985-09-05
• K842045 — WOODLYN CLASSIC EXAM. CHAIRWoodlyn, Inc.·1984-06-19
• K833539 — DOWING OPHTHALMIC CHAIR AC-POWEREDVision Health Technology·1984-03-05
• K801638 — A O CUSTOM II CHAIR AND STANDAmerican Optical Corp.·1980-08-13
• K781801 — MAXI-CHAIRSurgical Mechanical Research, Inc.·1978-11-03