Question 1

Who is the manufacturer of PNEUMOSCREEN?

Accepted Answer

Erich Jaeger, Inc. filed the 510(k) submission for PNEUMOSCREEN (K843849).

Question 2

What is the FDA product code for PNEUMOSCREEN?

Accepted Answer

BZC. It is classified under 21 CFR 868.1880 as a Class 2 device in the Anesthesiology panel.

Question 3

When was PNEUMOSCREEN cleared by the FDA?

Accepted Answer

Oct 16, 1984 (decision: SESE).

Question 4

What is the regulatory pathway for PNEUMOSCREEN?

Accepted Answer

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

Question 5

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

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	K843849
Device Name	PNEUMOSCREEN
Applicant	Erich Jaeger, Inc.
Product Code	BZC · Anesthesiology
Decision Date	Oct 16, 1984
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1880
Device Class	Class 2

PNEUMOSCREEN

Device Facts

Regulatory Classification

Identification