Ventilator, Non-continuous (Respirator)
FDA 510(k) K201439 · Respironics, Inc.
510(k) numberK201439
Submission
- Device name
- Ventilator, Non-continuous (Respirator)
- Applicant
- Respironics, Inc.
Murrysville, PA, US - Received
- June 1, 2020
- Decision date
- September 25, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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| K243394 | AF531 Oro-Nasal SE Face MaskCBK · Traditional | 12/30/2024SE |
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| K202142 | Sleepware G3OLZ · Traditional | 10/29/2020SE |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced SystemBZD · Traditional | 07/10/2020SE |
| K183625 | SomnaPatchMNR · Traditional | 10/18/2019SE |
| K183226 | Care Orchestrator EssenceBZD · Traditional | 10/18/2019SE |
| K181170 | Trilogy Evo UniversalCBK · Traditional | 07/18/2019SE |
| K181166 | Trilogy EvoCBK · Traditional | 07/18/2019SE |
Questions and answers
When was Ventilator, Non-continuous (Respirator) cleared by the FDA?
Ventilator, Non-continuous (Respirator) (K201439) received a 510(k) decision of Substantially Equivalent on September 25, 2020, 116 days after the submission was received.
What is the product code of K201439?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.