Atlas FDA

KYT

6 FDA 510(k) clearances · Product code

36 daysmedian time to decision
83 days90th percentile
6clearances measured

FDA profile

Official device name
Light, Examination, Medical, Battery Powered
Device class
Class I (low risk)
Regulation
21 CFR 880.6350
Medical specialty
General Hospital
Flags
GMP exempt
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RecordFirmDate
OLYMPIC TRANS-LITE (K920782)Olympic Medical Corp.1992-03-27
SUN-LITE WHITE SPOT (K841588)Suncoast Medical Manufacturers, Inc.1984-05-22
C-LITE (K841589)Suncoast Medical Manufacturers, Inc.1984-05-22
PENLIGHT/SWAB HOLDER (K791001)Concept, Inc.1979-06-22
PENLIGHTS (K781228)Abco Dealers, Inc.1978-09-07
TYCOS DIAGNOSTIC PENLIGHT (K760972)Taylor Instrument Analytics Co.1977-01-26

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