Question 1

Who is the manufacturer of EASY BREATHER MODEL 100?

Accepted Answer

Progressive Productions , Ltd. filed the 510(k) submission for EASY BREATHER MODEL 100 (K893213).

Question 2

What is the FDA product code for EASY BREATHER MODEL 100?

Accepted Answer

BYT. It is classified under 21 CFR 868.5935 as a Class 2 device in the Anesthesiology panel.

Question 3

When was EASY BREATHER MODEL 100 cleared by the FDA?

Accepted Answer

Aug 4, 1989 (decision: SESE).

Question 4

What is the regulatory pathway for EASY BREATHER MODEL 100?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like EASY BREATHER 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	K893213
Device Name	EASY BREATHER MODEL 100
Applicant	Progressive Productions , Ltd.
Product Code	BYT · Anesthesiology
Decision Date	Aug 4, 1989
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5935
Device Class	Class 2

EASY BREATHER MODEL 100

Device Facts

Regulatory Classification

Identification