Medical Device Manufacturer · US , Wooster , OH

Prentke Romich Co. - FDA 510(k) Cleared Devices

9 submissions · 7 cleared · Since 1990

Total

Cleared

Denied

Prentke Romich Co. has 7 FDA 510(k) cleared medical devices. Based in Wooster, US.

Historical record: 7 cleared submissions from 1990 to 1996. Primary specialty: Physical Medicine.

Browse the FDA 510(k) cleared devices submitted by Prentke Romich Co. Filter by specialty or product code using the sidebar.

Prentke Romich Co. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Prentke Romich Co.

9 devices

1-9 of 9

Cleared Jun 27, 1996

DELTATALKER WITH INFRARED

K961306 · IQA

Physical Medicine · 84d

Cleared Feb 21, 1995

SCANNING DIRECTOR

K944585 · IQA

Physical Medicine · 155d

Cleared Mar 28, 1994

WALKERTALKER

K933207 · ITI

Physical Medicine · 270d

Cleared Mar 28, 1994

ALPHA TALKER

K935317 · ITI

Physical Medicine · 144d

Cleared Mar 29, 1993

LIBERATOR

K925387 · ILQ

Physical Medicine · 154d

Cleared Mar 22, 1993

LIGHT TALKER

K925527 · ILQ

Physical Medicine · 140d

Cleared Feb 27, 1992

TOUCH TALKER

K914259 · ILQ

Physical Medicine · 157d

Cleared Jul 25, 1990

HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1

K902664 · IQA

Physical Medicine · 37d

Cleared May 29, 1990

CONTROL 1 ENVIRONMENTAL CONTROL

K902206 · ILQ

Physical Medicine · 13d

Prentke Romich Co. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Prentke Romich Co.

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