Question 1

Who is the manufacturer of MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM?

Accepted Answer

Alpha Technologies, Inc. filed the 510(k) submission for MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM (K852677).

Question 2

What is the FDA product code for MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM?

Accepted Answer

BZG. It is classified under 21 CFR 868.1840 as a Class 2 device in the Anesthesiology panel.

Question 3

When was MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM cleared by the FDA?

Accepted Answer

Jul 19, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM?

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	K852677
Device Name	MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM
Applicant	Alpha Technologies, Inc.
Product Code	BZG · Anesthesiology
Decision Date	Jul 19, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1840
Device Class	Class 2

MTS4400 METABOLIC & RESPIRATORY TESTING SYSTEM

Device Facts

Regulatory Classification

Identification