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Acoh Wellness Tester

by Bradley, Campbell & Carney 510(k)

Active United States

510(k) K830954

Overview

The Acoh Wellness Tester is a calculator for pulmonary function data, classified as a class 2 device. It is used in the field of anesthesiology.

The device is supplied with a product code of BZC and regulation number 868.1880. It has been authorized with an FDA 510K clearance, with a decision description of Substantially Equivalent. The device is associated with multiple FEI numbers and registration numbers, and is manufactured by Bradley, Campbell & Carney.

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

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830954 Date10 Jun 1983ClearedStatusActive

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 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
BZC
Device Class
Class II
Regulation
21 CFR Part 868.1880
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Acoh Wellness Tester used for?

    The Acoh Wellness Tester is a calculator specifically designed for pulmonary function data, used in the field of anesthesiology to assist with calculations related to patient respiratory function.

  • How is the Acoh Wellness Tester supplied and what are its regulatory details?

    The device is supplied with a product code of BZC and regulation number 868.1880. It has received FDA 510K clearance with a decision description of Substantially Equivalent, indicating it meets the necessary safety and effectiveness requirements for its intended use.

  • Is the Acoh Wellness Tester a single-use or reusable device?

    The device data does not specify whether the Acoh Wellness Tester is designed for single-use or multiple uses. For specific information regarding its intended use pattern, users should consult the manufacturer's documentation or contact Bradley, Campbell & Carney directly.

  • What are the storage requirements for the Acoh Wellness Tester?

    The device data does not include specific storage requirements for the Acoh Wellness Tester. Users should refer to the manufacturer's instructions for proper storage conditions to maintain device functionality and longevity.