Atlas FDA

HLH

2 FDA 510(k) clearances · Product code

FDA profile

Official device name
Pupillometer, Manual
Device class
Class I (low risk)
Regulation
21 CFR 886.1700
Medical specialty
Ophthalmic
Flags
GMP exempt
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RecordFirmDateBuilder
TRIAL LENS SET (K821082)Medical Equipment Designs, Inc.1982-06-14+ Add
P.D. METER (K821083)Medical Equipment Designs, Inc.1982-06-14+ Add

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Every clearance here is in the API, with alerts when new ones post.