Question 1

Who is the manufacturer of NASCOR OXYDOME?

Accepted Answer

Nascor Pty. , Ltd. filed the 510(k) submission for NASCOR OXYDOME (K905627).

Question 2

What is the FDA product code for NASCOR OXYDOME?

Accepted Answer

BYL. It is classified under 21 CFR 868.5700 as a Class 1 device in the Anesthesiology panel.

Question 3

When was NASCOR OXYDOME cleared by the FDA?

Accepted Answer

Jun 3, 1991 (decision: SESE).

Question 4

What is the regulatory pathway for NASCOR OXYDOME?

Accepted Answer

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

Question 5

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

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	K905627
Device Name	NASCOR OXYDOME
Applicant	Nascor Pty. , Ltd.
Product Code	BYL · Anesthesiology
Decision Date	Jun 3, 1991
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5700
Device Class	Class 1

NASCOR OXYDOME

Device Facts

Regulatory Classification

Identification