Question 1

Who is the manufacturer of BREATHING CIRCUIT, BAIN?

Accepted Answer

Respiratory Care, Inc. filed the 510(k) submission for BREATHING CIRCUIT, BAIN (K780044).

Question 2

What is the FDA product code for BREATHING CIRCUIT, BAIN?

Accepted Answer

CAI. It is classified under 21 CFR 868.5240 as a Class 1 device in the Anesthesiology panel.

Question 3

When was BREATHING CIRCUIT, BAIN cleared by the FDA?

Accepted Answer

Feb 2, 1978 (decision: SESE).

Question 4

What is the regulatory pathway for BREATHING CIRCUIT, BAIN?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like BREATHING CIRCUIT, BAIN?

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	K780044
Device Name	BREATHING CIRCUIT, BAIN
Applicant	Respiratory Care, Inc.
Product Code	CAI · Anesthesiology
Decision Date	Feb 2, 1978
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5240
Device Class	Class 1

BREATHING CIRCUIT, BAIN

Device Facts

Regulatory Classification

Identification