Question 1

Who is the manufacturer of ECONO MATE?

Accepted Answer

Mountain Medical Equipment, Inc. filed the 510(k) submission for ECONO MATE (K843715).

Question 2

What is the FDA product code for ECONO MATE?

Accepted Answer

CAW. It is classified under 21 CFR 868.5440 as a Class 2 device in the Anesthesiology panel.

Question 3

When was ECONO MATE cleared by the FDA?

Accepted Answer

Oct 10, 1984 (decision: SESE).

Question 4

What is the regulatory pathway for ECONO MATE?

Accepted Answer

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

Question 5

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

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	K843715
Device Name	ECONO MATE
Applicant	Mountain Medical Equipment, Inc.
Product Code	CAW · Anesthesiology
Decision Date	Oct 10, 1984
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5440
Device Class	Class 2

ECONO MATE

Device Facts

Regulatory Classification

Identification