Airmed Pneumatic Equip. Filtra/Control

FDA 510(k) K820079 · James L. Geraci & Associates, Inc.

Substantially Equivalent

510(k) numberK820079

Submission

Device name
Airmed Pneumatic Equip. Filtra/Control
Applicant
James L. Geraci & Associates, Inc.
Mchenry, IL, US
Received
January 12, 1982
Decision date
February 5, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BTI – Compressor, Air, Portable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.6250
Specialty
Anesthesiology

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More from eVent Medical, Ltd.

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K853927Lase System II · Traditional 10/16/1985SE
K820091Airmed Smoke Evacuation & FilterCIE · Traditional 02/24/1982SE
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Questions and answers

When was Airmed Pneumatic Equip. Filtra/Control cleared by the FDA?

Airmed Pneumatic Equip. Filtra/Control (K820079) received a 510(k) decision of Substantially Equivalent on February 5, 1982, 24 days after the submission was received.

What is the product code of K820079?

The FDA product code is BTI – Compressor, Air, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.6250.