Question 1

Who is the manufacturer of DEL MAR MODEL 5500 EEG SCANNER?

Accepted Answer

Del Mar Avionics filed the 510(k) submission for DEL MAR MODEL 5500 EEG SCANNER (K822700).

Question 2

What is the FDA product code for DEL MAR MODEL 5500 EEG SCANNER?

Accepted Answer

GWQ. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

Question 3

When was DEL MAR MODEL 5500 EEG SCANNER cleared by the FDA?

Accepted Answer

Oct 4, 1982 (decision: SESE).

Question 4

What is the regulatory pathway for DEL MAR MODEL 5500 EEG SCANNER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like DEL MAR MODEL 5500 EEG SCANNER?

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	K822700
Device Name	DEL MAR MODEL 5500 EEG SCANNER
Applicant	Del Mar Avionics
Product Code	GWQ · Neurology
Decision Date	Oct 4, 1982
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2

DEL MAR MODEL 5500 EEG SCANNER

Device Facts

Regulatory Classification

Identification