Product code HIT— Ophthalmic

FDA has cleared 9 devices under product code HIT between 1981 and 1991, filed by 8 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.

• 19911 clearance
• 19881 clearance
• 19872 clearances
• 19852 clearances
• 19841 clearance
• 19831 clearance
• 19811 clearance

• Richmond Products, Inc.2 clearances
• Visidyne Corp.1 clearance
• Titmus Optical, Inc.1 clearance
• Luneau Laboratories1 clearance
• Lkc Technologies, Inc.1 clearance
• Keeler Instruments, Inc.1 clearance
• Gynopharma, Inc.1 clearance
• Carl Zeiss, Inc.1 clearance

• K903001 — SLIMCATH (TM)Gynopharma, Inc.·1991-06-25
• K875026 — ANOMALOSCOPE PLATE TEST - 5 [APT-5]Lkc Technologies, Inc.·1988-02-05
• K873908 — H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK.Richmond Products, Inc.·1987-12-23
• K873911 — PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15Richmond Products, Inc.·1987-12-02
• K844694 — TITMUS VISION TESTER IITitmus Optical, Inc.·1985-01-22
• K844365 — COLOR VISION TESTERSLuneau Laboratories·1985-01-02
• K832843 — OSCAR COLOUR VISION TESTERKeeler Instruments, Inc.·1984-01-04
• K831074 — OSCAR COLOR VISION TESTERCarl Zeiss, Inc.·1983-04-28
• K810700 — CHROMOPS FM-100 COLOR VISION TESTERVisidyne Corp.·1981-04-10