Question 1

Who is the manufacturer of MODEL 674 PACER ANALYZER?

Accepted Answer

Del Mar Avionics filed the 510(k) submission for MODEL 674 PACER ANALYZER (K792074).

Question 2

What is the FDA product code for MODEL 674 PACER ANALYZER?

Accepted Answer

DTC. It is classified under 21 CFR 870.3630 as a Class 2 device in the Cardiovascular panel.

Question 3

When was MODEL 674 PACER ANALYZER cleared by the FDA?

Accepted Answer

Dec 27, 1979 (decision: SESE).

Question 4

What is the regulatory pathway for MODEL 674 PACER ANALYZER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MODEL 674 PACER ANALYZER?

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	K792074
Device Name	MODEL 674 PACER ANALYZER
Applicant	Del Mar Avionics
Product Code	DTC · Cardiovascular
Decision Date	Dec 27, 1979
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.3630
Device Class	Class 2

MODEL 674 PACER ANALYZER

Device Facts

Regulatory Classification

Identification