Who is the manufacturer of EXTERNAL PACEMAKER TELECTRONICS TE200?

Seamed Corp. filed the 510(k) submission for EXTERNAL PACEMAKER TELECTRONICS TE200 (K852746).

What is the FDA product code for EXTERNAL PACEMAKER TELECTRONICS TE200?

JOQ. It is classified under 21 CFR 870.1750 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for EXTERNAL PACEMAKER TELECTRONICS TE200?

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

Who can help prepare an FDA 510(k) submission like EXTERNAL PACEMAKER TELECTRONICS TE200?

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.

EXTERNAL PACEMAKER TELECTRONICS TE200

K852746 · Seamed Corp. · JOQ · Sep 12, 1985 · Cardiovascular

Device Facts

Record ID	K852746
Device Name	EXTERNAL PACEMAKER TELECTRONICS TE200
Applicant	Seamed Corp.
Product Code	JOQ · Cardiovascular
Decision Date	Sep 12, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1750
Device Class	Class 2

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