Question 1

Who is the manufacturer of BRONCHITRAC L?

Accepted Answer

Ackrad Laboratories filed the 510(k) submission for BRONCHITRAC L (K850784).

Question 2

What is the FDA product code for BRONCHITRAC L?

Accepted Answer

BSY. It is classified under 21 CFR 868.6810 as a Class 1 device in the Anesthesiology panel.

Question 3

When was BRONCHITRAC L cleared by the FDA?

Accepted Answer

Mar 25, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for BRONCHITRAC L?

Accepted Answer

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

Question 5

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

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	K850784
Device Name	BRONCHITRAC L
Applicant	Ackrad Laboratories
Product Code	BSY · Anesthesiology
Decision Date	Mar 25, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.6810
Device Class	Class 1

BRONCHITRAC L

Device Facts

Regulatory Classification

Identification