Question 1

Who is the manufacturer of TRACER?

Accepted Answer

Life-Tech Intl., Inc. filed the 510(k) submission for TRACER (K881842).

Question 2

What is the FDA product code for TRACER?

Accepted Answer

BXN. It is classified under 21 CFR 868.2775 as a Class 2 device in the Anesthesiology panel.

Question 3

When was TRACER cleared by the FDA?

Accepted Answer

Aug 31, 1988 (decision: SESE).

Question 4

What is the regulatory pathway for TRACER?

Accepted Answer

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

Question 5

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

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	K881842
Device Name	TRACER
Applicant	Life-Tech Intl., Inc.
Product Code	BXN · Anesthesiology
Decision Date	Aug 31, 1988
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2775
Device Class	Class 2

TRACER

Device Facts

Regulatory Classification

Identification