Provent Nasal Cannula
FDA 510(k) K080983 · Ventus Medical, Inc.
510(k) numberK080983
Submission
- Device name
- Provent Nasal Cannula
- Applicant
- Ventus Medical, Inc.
Belmont, CA, US - Received
- April 7, 2008
- Decision date
- August 7, 2008
- 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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| K090398 | Provent Professional Sleep Apnea TherapyOHP · Traditional | 04/03/2009SE |
| K071560 | Provent Nasal Dilator, Model BR2OHP · Traditional | 02/08/2008SE |
Questions and answers
When was Provent Nasal Cannula cleared by the FDA?
Provent Nasal Cannula (K080983) received a 510(k) decision of Substantially Equivalent on August 7, 2008, 122 days after the submission was received.
What is the product code of K080983?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.