Atlas FDA

ILP

21 FDA 510(k) clearances · Product code

16 daysmedian time to decision
27 days90th percentile
21clearances measured

FDA profile

Official device name
System, Communication, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 890.3700
Medical specialty
Physical Medicine
Flags
GMP exempt
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RecordFirmDate
TELL ME TAGS - NONPOWERED COMMUNICATION SYS (K844890)Mina Manufacturers, Inc.1985-03-08
SPEECH TEACHER (K840112)Joseph A. Resnick1984-03-22
ADAPTIVE PENS & LAP DESK (K831546)Fred Sammons, Inc.1983-06-08
MOUTH STICK KIT (K823625)Fred Sammons, Inc.1982-12-30
PICTURES & WORD IDENTIFICATION CVA PAT (K823608)Fred Sammons, Inc.1982-12-30
HOLDER FOR MOUTH STICK (K823624)Fred Sammons, Inc.1982-12-30
ADJ. WOODEN BOARD FOR WRITING (K823612)Fred Sammons, Inc.1982-12-30
KIT OF WORDS & LTRS TO RE-LEARN-BK4014 (K823609)Fred Sammons, Inc.1982-12-22
PLASTIC SLIP-ON PEN/PENCIL HOLDER (K823616)Fred Sammons, Inc.1982-12-22
FLEXIBLE HOLDER TO HOLD PHONE RECEIVER (K823614)Fred Sammons, Inc.1982-12-22
BK-4015 ECONOMY COMMUNICATION SHEET (K823610)Fred Sammons, Inc.1982-12-22
PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR (K823617)Fred Sammons, Inc.1982-12-22
PLASTIC STOP TO HOLD TELEPHONE BUTTON (K823613)Fred Sammons, Inc.1982-12-22
TELEPHONE ADAPTOR-PERSONS CANT ANSWER (K823615)Fred Sammons, Inc.1982-12-22
VACUUM WAND AND UNI-READER (K821644)Fred Sammons, Inc.1982-06-11
STIM STAND (K811483)Fred Sammons, Inc.1981-06-16
BOOK HOLDER (K811487)Fred Sammons, Inc.1981-06-12
NON-POWERED COMMUNICATION SYSTEMS (K810452)Fred Sammons, Inc.1981-03-04
BOOK HOLDER (K781204)Fred Sammons, Inc.1978-07-31
PAGE TURNER (K770032)Possum, Inc.1977-01-12
KEYBOARD SHEILDS (K761117)Fred Sammons, Inc.1976-12-02

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