Therapy Mask 3100 NC/SP
FDA 510(k) K231313 · Respironics, Inc.
510(k) numberK231313
Submission
- Device name
- Therapy Mask 3100 NC/SP
- Applicant
- Respironics, Inc.
Murrysville, PA, US - Received
- May 5, 2023
- Decision date
- July 28, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K201439 | Ventilator, Non-continuous (Respirator)BZD · Traditional | 09/25/2020SE |
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| 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 Therapy Mask 3100 NC/SP cleared by the FDA?
Therapy Mask 3100 NC/SP (K231313) received a 510(k) decision of Substantially Equivalent on July 28, 2023, 84 days after the submission was received.
What is the product code of K231313?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.