Question 1

Who is the manufacturer of VIBRO-COM COMMUNICATOR #8827?

Accepted Answer

Sonic Systems, Inc. filed the 510(k) submission for VIBRO-COM COMMUNICATOR #8827 (K813057).

Question 2

What is the FDA product code for VIBRO-COM COMMUNICATOR #8827?

Accepted Answer

LRA. as a Class U device in the EN panel.

Question 3

When was VIBRO-COM COMMUNICATOR #8827 cleared by the FDA?

Accepted Answer

Dec 2, 1981 (decision: SESE).

Question 4

What is the regulatory pathway for VIBRO-COM COMMUNICATOR #8827?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like VIBRO-COM COMMUNICATOR #8827?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K813057
Device Name	VIBRO-COM COMMUNICATOR #8827
Applicant	Sonic Systems, Inc.
Product Code	LRA · EN
Decision Date	Dec 2, 1981
Decision	SESE
Submission Type	Traditional
Device Class	Class U

VIBRO-COM COMMUNICATOR #8827

Device Facts