Question 1

Who is the manufacturer of CYBER DX 100?

Accepted Answer

Cyber Diagnostics filed the 510(k) submission for CYBER DX 100 (K791229).

Question 2

What is the FDA product code for CYBER DX 100?

Accepted Answer

BZM. It is classified under 21 CFR 868.1900 as a Class 2 device in the Anesthesiology panel.

Question 3

When was CYBER DX 100 cleared by the FDA?

Accepted Answer

Jul 30, 1979 (decision: SESE).

Question 4

What is the regulatory pathway for CYBER DX 100?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like CYBER DX 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	K791229
Device Name	CYBER DX 100
Applicant	Cyber Diagnostics
Product Code	BZM · Anesthesiology
Decision Date	Jul 30, 1979
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1900
Device Class	Class 2

CYBER DX 100

Device Facts

Regulatory Classification

Identification