Question 1

Who is the manufacturer of MISTMASTER?

Accepted Answer

Sonora Respiratory Products, Inc. filed the 510(k) submission for MISTMASTER (K872315).

Question 2

What is the FDA product code for MISTMASTER?

Accepted Answer

CCQ. It is classified under 21 CFR 868.5640 as a Class 1 device in the Anesthesiology panel.

Question 3

When was MISTMASTER cleared by the FDA?

Accepted Answer

Sep 11, 1987 (decision: SESE).

Question 4

What is the regulatory pathway for MISTMASTER?

Accepted Answer

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

Question 5

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

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	K872315
Device Name	MISTMASTER
Applicant	Sonora Respiratory Products, Inc.
Product Code	CCQ · Anesthesiology
Decision Date	Sep 11, 1987
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5640
Device Class	Class 1

MISTMASTER

Device Facts

Regulatory Classification

Identification