Alice PDX
FDA 510(k) K090484 · Respironics Inc., Sleep & Home Respiratory Group
510(k) numberK090484
Submission
- Device name
- Alice PDX
- Applicant
- Respironics Inc., Sleep & Home Respiratory Group
Murrysville, PA, US - Received
- February 25, 2009
- Decision date
- June 26, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNR – Ventilatory Effort Recorder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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| K242224 | Happy Health Home Sleep TestMNR · Traditional | Happy Health, Inc. | 06/18/2025SE |
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| K091271 | Respironics Performax Total Face MaskBZD · Special | 05/29/2009SE |
| K090243 | Remstar M-Series Auto with Aflex CPAP SystemBZD · Special | 05/08/2009SE |
| K083526 | Trilogy 100 VentilatorCBK · Abbreviated | 03/13/2009SE |
Questions and answers
When was Alice PDX cleared by the FDA?
Alice PDX (K090484) received a 510(k) decision of Substantially Equivalent on June 26, 2009, 121 days after the submission was received.
What is the product code of K090484?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.