Spiromate AS-600

FDA 510(k) K862023 · Riko Medical & Scientific Instrument Corp.

Substantially Equivalent

510(k) numberK862023

Submission

Device name
Spiromate AS-600
Applicant
Riko Medical & Scientific Instrument Corp.
Lake Success, NY, US
Received
May 28, 1986
Decision date
June 17, 1986
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 Spiromate AS-600 cleared by the FDA?

Spiromate AS-600 (K862023) received a 510(k) decision of Substantially Equivalent on June 17, 1986, 20 days after the submission was received.

What is the product code of K862023?

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