Question 1

Who is the manufacturer of METABOLIC EXERCISE TESTING SYSTEM?

Accepted Answer

Warren E. Collins, Inc. filed the 510(k) submission for METABOLIC EXERCISE TESTING SYSTEM (K831780).

Question 2

What is the FDA product code for METABOLIC EXERCISE TESTING SYSTEM?

Accepted Answer

BZL. It is classified under 21 CFR 868.1730 as a Class 2 device in the Anesthesiology panel.

Question 3

When was METABOLIC EXERCISE TESTING SYSTEM cleared by the FDA?

Accepted Answer

Sep 12, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for METABOLIC EXERCISE TESTING SYSTEM?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like METABOLIC EXERCISE 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	K831780
Device Name	METABOLIC EXERCISE TESTING SYSTEM
Applicant	Warren E. Collins, Inc.
Product Code	BZL · Anesthesiology
Decision Date	Sep 12, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1730
Device Class	Class 2

METABOLIC EXERCISE TESTING SYSTEM

Device Facts

Regulatory Classification

Identification