Question 1

Who is the manufacturer of RESPIGRAPH?

Accepted Answer

Respitrace Corp. filed the 510(k) submission for RESPIGRAPH (K854956).

Question 2

What is the FDA product code for RESPIGRAPH?

Accepted Answer

BZK. It is classified under 21 CFR 868.1850 as a Class 2 device in the Anesthesiology panel.

Question 3

When was RESPIGRAPH cleared by the FDA?

Accepted Answer

Mar 20, 1986 (decision: SESE).

Question 4

What is the regulatory pathway for RESPIGRAPH?

Accepted Answer

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

Question 5

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

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	K854956
Device Name	RESPIGRAPH
Applicant	Respitrace Corp.
Product Code	BZK · Anesthesiology
Decision Date	Mar 20, 1986
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1850
Device Class	Class 2

RESPIGRAPH

Device Facts

Regulatory Classification

Identification