Drive Solstice Oxygen Concentrator

FDA 510(k) K080391 · Medical Depot

Substantially Equivalent

510(k) numberK080391

Submission

Device name
Drive Solstice Oxygen Concentrator
Applicant
Medical Depot
Appollo Beach, FL, US
Received
February 13, 2008
Decision date
March 18, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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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Questions and answers

When was Drive Solstice Oxygen Concentrator cleared by the FDA?

Drive Solstice Oxygen Concentrator (K080391) received a 510(k) decision of Substantially Equivalent on March 18, 2008, 34 days after the submission was received.

What is the product code of K080391?

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