Product code HRM

Device name: Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Medical specialty: General, Plastic Surgery
Device class: 1
Regulation number: 878.4700
Review panel: SU
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K932720	HM-0970	Hill-Med, Inc.	1993-09-07
K930439	MARCO SURGISCOPE OPERATION MICROSCOPES	Marco Ophthalmic, Inc.	1993-07-22
K920641	ALCON OPERATING MICROSCOPES	Alcon Laboratories	1992-10-09
K914956	KEELER KONAN SPECULAR MICROSCOPE SP5500	Keeler Instruments, Inc.	1992-02-03
K891584	S 22 INSTRUMENT STAND	Carl Zeiss, Inc.	1989-06-08
K891001	MICROSCOPE KNOB COVER, STERILE, DISPOSABLE	Prescott'S, Inc.	1989-04-11
K854440	MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50	Keeler Instruments, Inc.	1985-12-16
K853855	XTAL X-150 OPERATING MICROSCOPE	Xtal Corp.	1985-10-15
K852586	CROMIC SURGICAL MICROSCOPE MODEL MC-1	Seltrex, Corp.	1985-07-30
K852150	CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500	Keeler Instruments, Inc.	1985-06-03
K850270	CORNEAL LIGHT SHIELD	Mentor O & O, Inc.	1985-05-31
K844323	KONAN CLINIC MICROSCOPE CLM-100-150	Keeler Instruments, Inc.	1984-11-21
K822563	OPHTHALMIC MICROSCOPE	Treace Medical, Inc.	1982-09-14
K792083	HAAG-STREIT SLIT LAMP 900	Lumenis, Inc.	1979-11-16

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00380650008374	UNITY	Alcon Laboratories, Inc.	2026-04-09
00380650008381	UNITY	Alcon Laboratories, Inc.	2026-04-09
00380650008398	UNITY	Alcon Laboratories, Inc.	2026-04-09
00380650008404	UNITY	Alcon Laboratories, Inc.	2026-04-09
07630802403711	PROVEO 8x	Leica Microsystems (Schweiz) AG	2025-10-03
17290115960591	Microscope Cover MITAKA mm80, mm90, 80/266	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2025-06-11
27290115960598	Microscope Cover MITAKA mm80, mm90, 80/266	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2025-06-11
B366MC025	PROCAM HD 2D	Ecleris	2025-01-16
00836230000189	Microscope Cover LEICA 137/380 7.00	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000554	Microscope Cover LEICA 137/380 7.00 HLT	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000196	Microscope Cover ZEISS 137/380 6.50	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000332	"Microscope Cover ZEISS ""MD"" 137/330 6.50 HLT"	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000363	Microscope Cover LEICA 115/300, 7 HLT	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000370	Microscope Cover LEICA 137/380 7.00 HLT	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000387	Microscope Cover LEICA 115/300 10.50	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000400	"Microscope Cover ZEISS ""MD"" 115/300 6.50 HLT"	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000431	Microscope Cover ZEISS 137/380 6.50 HLT	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000509	Microscope Cover LEICA 137/380 7.00 HLT	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000516	"Microscope Cover ZEISS ""MD"" 115/300 6.50"	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000158	Microscope Cover LEICA 50/180 7.00	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000141	Microscope Cover LEICA 115/180 7.0 HLT	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000127	"Microscope Cover ZEISS ""MD"" 115/260 6.50"	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000103	"Microscope Cover ZEISS ""MD"" 115/180 6.50"	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000073	Microscope Cover LEICA 115/300 7.00	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000066	Microscope Cover LEICA 115/260 7.00	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000059	"Microscope Cover ZEISS ""OPMI"" 115/260 4.85"	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000042	"Microscope Cover ZEISS ""OPMI"" 50/180 4.85"	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000035	Microscope Cover LEICA 115/180 7.00	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000028	"Microscope Cover ZEISS ""OPMI"" 115/180 4.85"	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16
00836230000011	"Microscope Cover ZEISS ""MD"" 50/180 6.50"	PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.	2022-11-16

Product code HRM

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