Handtymp Screener Model 2000 + 2002 Remote Trans.

FDA 510(k) K890864 · Rastronics USA, Inc.

Substantially Equivalent

510(k) numberK890864

Submission

Device name
Handtymp Screener Model 2000 + 2002 Remote Trans.
Applicant
Rastronics USA, Inc.
Bensenville, IL, US
Received
February 21, 1989
Decision date
June 21, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ETY – Tester, Auditory Impedance
Device class
Class II (moderate risk)
Regulation
21 CFR 874.1090
Specialty
Ear, Nose, Throat

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Questions and answers

When was Handtymp Screener Model 2000 + 2002 Remote Trans. cleared by the FDA?

Handtymp Screener Model 2000 + 2002 Remote Trans. (K890864) received a 510(k) decision of Substantially Equivalent on June 21, 1989, 120 days after the submission was received.

What is the product code of K890864?

The FDA product code is ETY – Tester, Auditory Impedance, a Class II (moderate risk) device regulated under 21 CFR 874.1090.