Question 1

Who is the manufacturer of UNIVERSAL JET VENTILATOR MODEL AMS-1000?

Accepted Answer

Acutronic Medical Systems AG filed the 510(k) submission for UNIVERSAL JET VENTILATOR MODEL AMS-1000 (K863155).

Question 2

What is the FDA product code for UNIVERSAL JET VENTILATOR MODEL AMS-1000?

Accepted Answer

CBK. It is classified under 21 CFR 868.5895 as a Class 2 device in the Anesthesiology panel.

Question 3

When was UNIVERSAL JET VENTILATOR MODEL AMS-1000 cleared by the FDA?

Accepted Answer

Sep 28, 1987 (decision: SESE).

Question 4

What is the regulatory pathway for UNIVERSAL JET VENTILATOR MODEL AMS-1000?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like UNIVERSAL JET VENTILATOR MODEL AMS-1000?

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	K863155
Device Name	UNIVERSAL JET VENTILATOR MODEL AMS-1000
Applicant	Acutronic Medical Systems AG
Product Code	CBK · Anesthesiology
Decision Date	Sep 28, 1987
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5895
Device Class	Class 2

UNIVERSAL JET VENTILATOR MODEL AMS-1000

Device Facts

Regulatory Classification

Identification