Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605
FDA 510(k) K043006 · Respironics, Inc.
510(k) numberK043006
Submission
- Device name
- Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605
- Applicant
- Respironics, Inc.
Murrysville, PA, US - Received
- November 1, 2004
- Decision date
- February 11, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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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| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)CAW · Traditional | Devilbiss Healthcare, LLC | 12/09/2025SE |
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Questions and answers
When was Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605 cleared by the FDA?
Millennium M10 Oxygen Concentrator, Model M10600; with Opi, Model M10605 (K043006) received a 510(k) decision of Substantially Equivalent on February 11, 2005, 102 days after the submission was received.
What is the product code of K043006?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.