Holter Performer

FDA 510(k) K813602 · Applied Cardiac Systems

Substantially Equivalent

510(k) numberK813602

Submission

Device name
Holter Performer
Applicant
Applied Cardiac Systems
Mchenry, IL, US
Received
December 28, 1981
Decision date
January 29, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DSH – Recorder, Magnetic Tape, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2800
Specialty
Cardiovascular

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More from Bardy Diagnostics, Inc.

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K103706The Core (Cardiac Outpatient Realtime ECG) MonitorQYX · Abbreviated 08/24/2011SE
K042413Acs Model NCP-2DRN · Traditional 12/09/2004SE
K860249The Holter Reporter (TM)DPS · Traditional 03/11/1986SE
K833823Holter Performer Feather Weight/CassDSH · Traditional 12/01/1983SE

Questions and answers

When was Holter Performer cleared by the FDA?

Holter Performer (K813602) received a 510(k) decision of Substantially Equivalent on January 29, 1982, 32 days after the submission was received.

What is the product code of K813602?

The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.