Flow Spirometer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K934502 ↗

FDA Product Code

BZH

Device Class

Class II

Regulation

21 CFR Part 868.1860

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Healthdyne Impluse Ventilator

  Class II

  FDA 510(k) K853300 Active Cleared 15 Aug 1985

• Oxygen Concentrator, Model Bx-5000

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• Healthdyne Event Recorder System

  Class II

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• Healthdyne Rate Meter

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• Oxygen/Pulse Monitor

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• Healthdyne's Apnea/Heart Monitor, Model 900S

  Class II

  FDA 510(k) K892006 Active Cleared 23 May 1989

See all devices from Healthdyne, Inc. →