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Pulse Wave Velocity Monitor P607

by Cyborg Corp. 510(k)

Active United States

510(k) K770330

Overview

The Pulse Wave Velocity Monitor P607 is a computer-based diagnostic device used to measure pulse wave velocity. It is a single-function, pre-programmed device. The device is classified as a class 2 device and is used in the cardiovascular medical specialty.

The device is supplied with a registration number and is regulated under regulation number 870.1435. It has been cleared through the traditional clearance type and has been found to be substantially equivalent. The device is manufactured by Cyborg Corp. and has been authorized by the FDA through the 510K process.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770330 Date24 Feb 1977ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

Full name
Monitor, Pulse Wave Velocity P607
510(k) Number
FDA Product Code
DXG
Device Class
Class II
Regulation
21 CFR Part 870.1435
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent