Question 1

Who is the manufacturer of ULTRACALM?

Accepted Answer

Sion Technology, Inc. filed the 510(k) submission for ULTRACALM (K910625).

Question 2

What is the FDA product code for ULTRACALM?

Accepted Answer

LWM. as a Class U device in the DE panel.

Question 3

When was ULTRACALM cleared by the FDA?

Accepted Answer

May 15, 1992 (decision: SESE).

Question 4

What is the regulatory pathway for ULTRACALM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ULTRACALM?

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	K910625
Device Name	ULTRACALM
Applicant	Sion Technology, Inc.
Product Code	LWM · DE
Decision Date	May 15, 1992
Decision	SESE
Submission Type	Traditional
Device Class	Class U

ULTRACALM

Device Facts