Question 1

Who is the manufacturer of CENTRALERT?

Accepted Answer

Draeger Medical, Inc. filed the 510(k) submission for CENTRALERT (K833147).

Question 2

What is the FDA product code for CENTRALERT?

Accepted Answer

BSZ. It is classified under 21 CFR 868.5160 as a Class 2 device in the Anesthesiology panel.

Question 3

When was CENTRALERT cleared by the FDA?

Accepted Answer

Dec 16, 1983 (decision: SESE).

Question 4

What is the regulatory pathway for CENTRALERT?

Accepted Answer

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

Question 5

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

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	K833147
Device Name	CENTRALERT
Applicant	Draeger Medical, Inc.
Product Code	BSZ · Anesthesiology
Decision Date	Dec 16, 1983
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5160
Device Class	Class 2

CENTRALERT

Device Facts

Regulatory Classification

Identification