Tracer

FDA 510(k) K881842 · Life-Tech Intl., Inc.

Substantially Equivalent

510(k) numberK881842

Submission

Device name
Tracer
Applicant
Life-Tech Intl., Inc.
Houston, TX, US
Received
May 2, 1988
Decision date
August 31, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BXN – Stimulator, Nerve, Battery-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2775
Specialty
Anesthesiology

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Questions and answers

When was Tracer cleared by the FDA?

Tracer (K881842) received a 510(k) decision of Substantially Equivalent on August 31, 1988, 121 days after the submission was received.

What is the product code of K881842?

The FDA product code is BXN – Stimulator, Nerve, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 868.2775.