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Vitalog PMS-8

by Vitalog Corp. 510(k)

Active United States

510(k) K845051

Overview

The VITALOG PMS-8 is an ear oximeter, which is an extravascular device used to transmit light at a known wavelength through blood in the ear. It is classified as a Class II cardiovascular device with the product code DPZ.

The device is manufactured by Vitalog Corp. and received FDA 510(k) clearance with the K-number K845051 on May 15, 1985. It is reviewed under the Cardiovascular advisory committee and is not a third-party device. The device is not described as single-use or reusable in the provided data.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK845051 Date15 May 1985ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DPZ
Device Class
Class II
Regulation
21 CFR Part 870.2710
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Vitalog Corp.

Questions

  • What is the VITALOG PMS-8 used for?

    The VITALOG PMS-8 is an ear oximeter, an extravascular device that transmits light at a known wavelength through blood in the ear to measure oxygen levels. It is classified as a Class II cardiovascular device with the product code DPZ.

  • Is the VITALOG PMS-8 a single-use or reusable device?

    The provided data does not specify whether the VITALOG PMS-8 is designed for single-use or reusable purposes. No information regarding sterility or disposal instructions is included in the device description.

  • What regulatory approvals does the VITALOG PMS-8 have?

    The VITALOG PMS-8 received FDA 510(k) clearance with K-number K845051 on May 15, 1985. It is manufactured by Vitalog Corp. and was reviewed under the Cardiovascular advisory committee, classified as substantially equivalent to other devices on the market.

  • How is the VITALOG PMS-8 supplied and stored?

    The device data does not include specific information about how the VITALOG PMS-8 is supplied or recommended storage conditions. For these details, users would need to consult the product's instructions for use or contact the manufacturer directly.