Discovery Graphic Portable Spirometer

FDA 510(k) K950223 · Futuremed America, Inc.

Substantially Equivalent

510(k) numberK950223

Submission

Device name
Discovery Graphic Portable Spirometer
Applicant
Futuremed America, Inc.
Deerpark, NY, US
Received
January 10, 1995
Decision date
November 17, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BZG – Spirometer, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1840
Specialty
Anesthesiology

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Questions and answers

When was Discovery Graphic Portable Spirometer cleared by the FDA?

Discovery Graphic Portable Spirometer (K950223) received a 510(k) decision of Substantially Equivalent on November 17, 1995, 311 days after the submission was received.

What is the product code of K950223?

The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.