Deuce

FDA 510(k) K943244 · Apt Technology, Inc.

Substantially Equivalent

510(k) numberK943244

Submission

Device name
Deuce
Applicant
Apt Technology, Inc.
Shreve, OH, US
Received
July 6, 1994
Decision date
September 11, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IQA – System, Environmental Control, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3725
Specialty
Physical Medicine

Other 510(k)s with product code IQA

510(k)DeviceApplicantDecision
K961306Deltatalker with InfraredIQA · Traditional Prentke Romich Co.06/27/1996SE
K953905ImperiumIQA · Traditional Teledyne Brown Engineering11/21/1995SE
K953937Liaison Computer Access & Environmental Control SystemIQA · Traditional Apt Technology, Inc.10/31/1995SE
K944585Scanning DirectorIQA · Traditional Prentke Romich Co.02/21/1995SE
K944345Bedside ButlerIQA · Traditional Trac Medical, Inc.10/17/1994SE
K940223Learn Mode Waterproof Pendant Panic ButtonIQA · Traditional Interactive Technologies, Inc.04/29/1994SE
K926029Infra-LinkIQA · Traditional Zygo Industries, Inc.03/26/1993SE
K921528Hill-Rom Patient Environmental Control SystemIQA · Traditional Hill-Rom, Inc.04/20/1992SE
K911101Tonguetouch Keypad and Zofcom Control SystemIQA · Traditional Zofcom, Inc.04/25/1991SE
K902664Hospital/Home Environmental Control SYST/HECS-1IQA · Traditional Prentke Romich Co.07/25/1990SE

More from Prentke Romich Co.

510(k)DeviceDecision
K953937Liaison Computer Access & Environmental Control SystemIQA · Traditional 10/31/1995SE

Questions and answers

When was Deuce cleared by the FDA?

Deuce (K943244) received a 510(k) decision of Substantially Equivalent on September 11, 1995, 432 days after the submission was received.

What is the product code of K943244?

The FDA product code is IQA – System, Environmental Control, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3725.