Device Type ID | 4191 |
Device Name | Ophthalmoscope, Battery-powered |
Regulation Description | Ophthalmoscope. |
Regulation Medical Specialty | Ophthalmic |
Review Panel | Ophthalmic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Contact Lenses And Retinal Devices Branch (CLRD) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 886.1570 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | HLJ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
|
Device Type ID | 4191 |
Device | Ophthalmoscope, Battery-powered |
Product Code | HLJ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Ophthalmoscope. |
CFR Regulation Number | 886.1570 [🔎] |
Premarket Reviews | ||
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Manufacturer | Decision | |
HEINE OPTOTECHNIK GMBH & CO. KG. | ||
SUBSTANTIALLY EQUIVALENT | 1 |