Magno Alarm

FDA 510(k) K960849 · Cardiac Assist Devices, Inc.

Substantially Equivalent

510(k) numberK960849

Submission

Device name
Magno Alarm
Applicant
Cardiac Assist Devices, Inc.
Cleveland, OH, US
Received
February 20, 1996
Decision date
March 26, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DTG – Magnet, Test, Pacemaker
Device class
Class I (low risk)
Regulation
21 CFR 870.3690
Specialty
Cardiovascular

Other 510(k)s with product code DTG

510(k)DeviceApplicantDecision
K092364Model 220 Patient MagnetDTG · Traditional Cyberonics, Inc.11/03/2009SE
K895110Maestro Pacemaker Test MagnetDTG · Traditional Cardiac Control Systems, Inc.09/26/1989SE
K831926Implantable Endocardial Pacing LeadsDTG · Traditional Oscor, Inc.03/12/1984SE
K813153Test MagnetDTG · Traditional Pacesetter Systems12/02/1981SE

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K012520Gyro-Tip Lariat Deflectable Loop Mapping Catheter, Model GTL-20EDRF · Traditional 03/27/2002SE
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Questions and answers

When was Magno Alarm cleared by the FDA?

Magno Alarm (K960849) received a 510(k) decision of Substantially Equivalent on March 26, 1997, 400 days after the submission was received.

What is the product code of K960849?

The FDA product code is DTG – Magnet, Test, Pacemaker, a Class I (low risk) device regulated under 21 CFR 870.3690.