Question 1

Who is the manufacturer of ANESTHESIA VENTILATOR MODEL 100?

Accepted Answer

Rusz Instruments, Inc. filed the 510(k) submission for ANESTHESIA VENTILATOR MODEL 100 (K854202).

Question 2

What is the FDA product code for ANESTHESIA VENTILATOR MODEL 100?

Accepted Answer

CAD. It is classified under 21 CFR 868.5880 as a Class 2 device in the Anesthesiology panel.

Question 3

When was ANESTHESIA VENTILATOR MODEL 100 cleared by the FDA?

Accepted Answer

Apr 11, 1986 (decision: SESE).

Question 4

What is the regulatory pathway for ANESTHESIA VENTILATOR MODEL 100?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ANESTHESIA VENTILATOR MODEL 100?

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	K854202
Device Name	ANESTHESIA VENTILATOR MODEL 100
Applicant	Rusz Instruments, Inc.
Product Code	CAD · Anesthesiology
Decision Date	Apr 11, 1986
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5880
Device Class	Class 2

ANESTHESIA VENTILATOR MODEL 100

Device Facts

Regulatory Classification

Identification