Medical Air Compressor

FDA 510(k) K113338 · Oricare, Inc.

Substantially Equivalent

510(k) numberK113338

Submission

Device name
Medical Air Compressor
Applicant
Oricare, Inc.
Quakertow., PA, US
Received
November 14, 2011
Decision date
August 10, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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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K041406Newport C250 Air Compressor Model C250BTI · Traditional Newport Medical Instruments12/15/2004SE
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More from Medline Industries, Inc.

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Questions and answers

When was Medical Air Compressor cleared by the FDA?

Medical Air Compressor (K113338) received a 510(k) decision of Substantially Equivalent on August 10, 2012, 270 days after the submission was received.

What is the product code of K113338?

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