SpiroCard

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K973138 ↗

FDA Product Code

BZG

Device Class

Class II

Regulation

21 CFR Part 868.1840

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Modification to: Bpcard, Model Z-7000-0700

  Class II

  FDA 510(k) K073630 Active Cleared 11 Jan 2008

• Spiroxcard Diagnostic Spirometer and Pulse Oximeter

  Class II

  FDA 510(k) K001995 Active Cleared 8 Sep 2000

• Sensaire Diagnostic Spirometer

  Class II

  FDA 510(k) K001278 Active Cleared 29 Nov 2000

• CARDIOVIEW32 Review Module

  Not classified

  FDA 510(k) K083749 Active Cleared 10 Mar 2009

• Ekgcard System

  Class II

  FDA 510(k) K030535 Active Cleared 11 Jun 2003

• BPCard

  Class II

  FDA 510(k) K031964 Active Cleared 5 Sep 2003

• What is the SpiroCard device used for?

  SpiroCard is a diagnostic spirometer device designed for measuring lung function parameters. It is intended for use in healthcare settings, particularly in anesthesiology and other medical specialties requiring pulmonary function assessment.

• How is the SpiroCard supplied and what is its classification?

  The SpiroCard is supplied as a PC Card family medical device and is classified as Class II under special controls. It received FDA 510(k) clearance on October 28, 1998, with product code BZG.

• Is the SpiroCard a single-use or reusable device?

  The device data does not specify whether the SpiroCard is single-use or reusable. However, as a PC Card family medical device designed for acquiring and communicating physiological data, it appears to be intended for multiple uses in healthcare settings.

• What regulatory approvals does the SpiroCard have?

  The SpiroCard has received FDA 510(k) clearance, which means it has been determined to be substantially equivalent to legally marketed predicate devices. It is classified as Class II under special controls with product code BZG.