HRM — Microscope, Operating & Accessories, Ac-Powered, Ophthalmic Class I

FDA Device Classification

Classification Details

Product Code
HRM
Device Class
Class I
Regulation Number
878.4700
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K932720hill-medHM-0970September 7, 1993
K930439marco ophthalmicMARCO SURGISCOPE OPERATION MICROSCOPESJuly 22, 1993
K920641alcon laboratoriesALCON OPERATING MICROSCOPESOctober 9, 1992
K914956keeler instrumentsKEELER KONAN SPECULAR MICROSCOPE SP5500February 3, 1992
K891584carl zeissS 22 INSTRUMENT STANDJune 8, 1989
K891001prescottMICROSCOPE KNOB COVER, STERILE, DISPOSABLEApril 11, 1989
K854440keeler instrumentsMODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50December 16, 1985
K853855xtalXTAL X-150 OPERATING MICROSCOPEOctober 15, 1985
K852586seltrexCROMIC SURGICAL MICROSCOPE MODEL MC-1July 30, 1985
K852150keeler instrumentsCLINICAL WIDEFIELD SPECULAR MICRISCOPE 500June 3, 1985
K850270mentor o and oCORNEAL LIGHT SHIELDMay 31, 1985
K844323keeler instrumentsKONAN CLINIC MICROSCOPE CLM-100-150November 21, 1984
K822563treace medicalOPHTHALMIC MICROSCOPESeptember 14, 1982
K792083lumenisHAAG-STREIT SLIT LAMP 900November 16, 1979