Question 1

Who is the manufacturer of RESPI-PAK RT-PAK?

Accepted Answer

Cns, Inc. filed the 510(k) submission for RESPI-PAK RT-PAK (K910452).

Question 2

What is the FDA product code for RESPI-PAK RT-PAK?

Accepted Answer

BZG. It is classified under 21 CFR 868.1840 as a Class 2 device in the Anesthesiology panel.

Question 3

When was RESPI-PAK RT-PAK cleared by the FDA?

Accepted Answer

Apr 16, 1991 (decision: SESE).

Question 4

What is the regulatory pathway for RESPI-PAK RT-PAK?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like RESPI-PAK RT-PAK?

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	K910452
Device Name	RESPI-PAK RT-PAK
Applicant	Cns, Inc.
Product Code	BZG · Anesthesiology
Decision Date	Apr 16, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1840
Device Class	Class 2

RESPI-PAK RT-PAK

Device Facts

Regulatory Classification

Identification