Acoustic Otocope Recorder

FDA 510(k) K850007 · Endeco Medical, Inc.

Substantially Equivalent

510(k) numberK850007

Submission

Device name
Acoustic Otocope Recorder
Applicant
Endeco Medical, Inc.
Marion, MA, US
Received
January 2, 1985
Decision date
March 1, 1985
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 Acoustic Otocope Recorder cleared by the FDA?

Acoustic Otocope Recorder (K850007) received a 510(k) decision of Substantially Equivalent on March 1, 1985, 58 days after the submission was received.

What is the product code of K850007?

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