CCA-100 (Modified)

FDA 510(k) K963681 · Benson Medical Instruments Co.

Substantially Equivalent

510(k) numberK963681

Submission

Device name
CCA-100 (Modified)
Applicant
Benson Medical Instruments Co.
Minneapolis, MN, US
Received
July 11, 1996
Decision date
October 8, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EWO – Audiometer
Device class
Class II (moderate risk)
Regulation
21 CFR 874.1050
Specialty
Ear, Nose, Throat

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More from Ihear Medical, Inc.

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K123896CCS-200 SpirometerBZG · Traditional 09/10/2013SE
K982441CCA-220EWO · Traditional 10/09/1998SE
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K924652Benson CCA100EWG · Traditional 04/09/1993SE

Questions and answers

When was CCA-100 (Modified) cleared by the FDA?

CCA-100 (Modified) (K963681) received a 510(k) decision of Substantially Equivalent on October 8, 1996, 89 days after the submission was received.

What is the product code of K963681?

The FDA product code is EWO – Audiometer, a Class II (moderate risk) device regulated under 21 CFR 874.1050.