Question 1

Who is the manufacturer of LASER SHIELDING TUBE?

Accepted Answer

Vitaid, Ltd. filed the 510(k) submission for LASER SHIELDING TUBE (K894669).

Question 2

What is the FDA product code for LASER SHIELDING TUBE?

Accepted Answer

BTR. It is classified under 21 CFR 868.5730 as a Class 2 device in the Anesthesiology panel.

Question 3

When was LASER SHIELDING TUBE cleared by the FDA?

Accepted Answer

Oct 13, 1989 (decision: SESE).

Question 4

What is the regulatory pathway for LASER SHIELDING TUBE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like LASER SHIELDING TUBE?

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	K894669
Device Name	LASER SHIELDING TUBE
Applicant	Vitaid, Ltd.
Product Code	BTR · Anesthesiology
Decision Date	Oct 13, 1989
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5730
Device Class	Class 2

LASER SHIELDING TUBE

Device Facts

Regulatory Classification

Identification