Question 1

Who is the manufacturer of MODEL 2120 SPIROSCREEN?

Accepted Answer

Gould, Inc. filed the 510(k) submission for MODEL 2120 SPIROSCREEN (K854403).

Question 2

What is the FDA product code for MODEL 2120 SPIROSCREEN?

Accepted Answer

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

Question 3

When was MODEL 2120 SPIROSCREEN cleared by the FDA?

Accepted Answer

Jan 14, 1986 (decision: SESE).

Question 4

What is the regulatory pathway for MODEL 2120 SPIROSCREEN?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MODEL 2120 SPIROSCREEN?

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	K854403
Device Name	MODEL 2120 SPIROSCREEN
Applicant	Gould, Inc.
Product Code	BZG · Anesthesiology
Decision Date	Jan 14, 1986
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1840
Device Class	Class 2

MODEL 2120 SPIROSCREEN

Device Facts

Regulatory Classification

Identification