Wristwatch Blood Pressure Monitor A46

FDA 510(k) K010498 · Rossmax Internationl , Ltd.

Substantially Equivalent

510(k) numberK010498

Submission

Device name
Wristwatch Blood Pressure Monitor A46
Applicant
Rossmax Internationl , Ltd.
Taipei, TW
Received
February 21, 2001
Decision date
March 20, 2001
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DXN – System, Measurement, Blood-Pressure, Non-Invasive
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1130
Specialty
Cardiovascular

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More from 80 Beats Medical GmbH

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Questions and answers

When was Wristwatch Blood Pressure Monitor A46 cleared by the FDA?

Wristwatch Blood Pressure Monitor A46 (K010498) received a 510(k) decision of Substantially Equivalent on March 20, 2001, 27 days after the submission was received.

What is the product code of K010498?

The FDA product code is DXN – System, Measurement, Blood-Pressure, Non-Invasive, a Class II (moderate risk) device regulated under 21 CFR 870.1130.