Presto Diagnostic Spirometer

FDA 510(k) K894997 · Tamarac Systems Corp.

Substantially Equivalent

510(k) numberK894997

Submission

Device name
Presto Diagnostic Spirometer
Applicant
Tamarac Systems Corp.
Denver, CO, US
Received
August 8, 1989
Decision date
October 30, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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More from Vitalograph Ireland, Ltd.

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Questions and answers

When was Presto Diagnostic Spirometer cleared by the FDA?

Presto Diagnostic Spirometer (K894997) received a 510(k) decision of Substantially Equivalent on October 30, 1989, 83 days after the submission was received.

What is the product code of K894997?

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