Question 1

Who is the manufacturer of MONITOR, PACEMAKER?

Accepted Answer

Adcor Electronics, Inc. filed the 510(k) submission for MONITOR, PACEMAKER (K770865).

Question 2

What is the FDA product code for MONITOR, PACEMAKER?

Accepted Answer

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

Question 3

When was MONITOR, PACEMAKER cleared by the FDA?

Accepted Answer

Jun 14, 1977 (decision: SESE).

Question 4

What is the regulatory pathway for MONITOR, PACEMAKER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MONITOR, PACEMAKER?

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	K770865
Device Name	MONITOR, PACEMAKER
Applicant	Adcor Electronics, Inc.
Product Code	DTC · Cardiovascular
Decision Date	Jun 14, 1977
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.3630
Device Class	Class 2

MONITOR, PACEMAKER

Device Facts

Regulatory Classification

Identification