Oxygen/Sterile Air Gen Syst/Surgical Handpieces

FDA 510(k) K873284 · Litton Systems, Inc.

Substantially Equivalent

510(k) numberK873284

Submission

Device name
Oxygen/Sterile Air Gen Syst/Surgical Handpieces
Applicant
Litton Systems, Inc.
Davenport, IA, US
Received
August 17, 1987
Decision date
November 16, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CAW – Generator, Oxygen, Portable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5440
Specialty
Anesthesiology

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More from Devilbiss Healthcare, LLC

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K013223Patient Ventilation Oxygen Concentrating System (Pvocs)CAW · Traditional 02/11/2002SE
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Questions and answers

When was Oxygen/Sterile Air Gen Syst/Surgical Handpieces cleared by the FDA?

Oxygen/Sterile Air Gen Syst/Surgical Handpieces (K873284) received a 510(k) decision of Substantially Equivalent on November 16, 1987, 91 days after the submission was received.

What is the product code of K873284?

The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.