Gsi 38 Auto Tymp

FDA 510(k) K925585 · Lucas Grason-Stadler, Inc.

Substantially Equivalent

510(k) numberK925585

Submission

Device name
Gsi 38 Auto Tymp
Applicant
Lucas Grason-Stadler, Inc.
Littleton, MA, US
Received
November 4, 1992
Decision date
February 2, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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 Gsi 38 Auto Tymp cleared by the FDA?

Gsi 38 Auto Tymp (K925585) received a 510(k) decision of Substantially Equivalent on February 2, 1993, 90 days after the submission was received.

What is the product code of K925585?

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