Tricot Blood Pressure Cuff

FDA 510(k) K051539 · Ya Horng Electronic Co., Ltd.

Substantially Equivalent

510(k) numberK051539

Submission

Device name
Tricot Blood Pressure Cuff
Applicant
Ya Horng Electronic Co., Ltd.
Hsin-Chu City, TW
Received
June 10, 2005
Decision date
August 5, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DXQ – Blood Pressure Cuff
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1120
Specialty
Cardiovascular

A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.

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More from Suzhou Minhua Medical Apparatus Supplies Co., Ltd.

510(k)DeviceDecision
K221486Index BPMDXN · Traditional 08/30/2022SE
K121025Ya Horng Blood Pressure Monitor, Ya Horng Blood Pressure Monitor, Bluetooth TransmissionDXN · Traditional 08/17/2012SE
K090058Ya Horng Digital Upper Arm Blood Pressure Monitor, BP-700, BP-700T, BP700U, BP-700B…DXN · Traditional 04/22/2009SE
K081590Ya Horng Arm Type Digital Blood Pressure Monitor, Models BP-600, BP-600R, BP-600U…DXN · Traditional 06/19/2008SE
K072860Ya Horng Digital Upper Arm Blood Pressure Monitor, BP-100J, BP-110J; Digital Wrist Blood…DXN · Traditional 02/25/2008SE
K051862PC Compatible Blood Pressure Monitor, Model AK-4000TU, BP-410U, BP-410R; Automatic…DXN · Traditional 08/23/2005SE
K051863Amluck, Ya HorngDXN · Traditional 08/19/2005SE
K042581Amluck, Ya HorngDXN · Traditional 10/13/2004SE
K040528Amluck Ya Horng PC Compatible Wrist Blood Pressure Monitor, Model AK-4000TDXN · Traditional 04/15/2004SE

Questions and answers

When was Tricot Blood Pressure Cuff cleared by the FDA?

Tricot Blood Pressure Cuff (K051539) received a 510(k) decision of Substantially Equivalent on August 5, 2005, 56 days after the submission was received.

What is the product code of K051539?

The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.