Spi-Rise

FDA 510(k) K822359 · Certified Respiratory Services, Inc.

Substantially Equivalent

510(k) numberK822359

Submission

Device name
Spi-Rise
Applicant
Certified Respiratory Services, Inc.
Mchenry, IL, US
Received
August 6, 1982
Decision date
August 27, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BWF – Spirometer, Therapeutic (Incentive)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5690
Specialty
Anesthesiology

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More from Teleflexmedical, Inc.

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Questions and answers

When was Spi-Rise cleared by the FDA?

Spi-Rise (K822359) received a 510(k) decision of Substantially Equivalent on August 27, 1982, 21 days after the submission was received.

What is the product code of K822359?

The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.