Invent Snoring Device
FDA 510(k) K120665 · Ventus Medical, Inc.
510(k) numberK120665
Submission
- Device name
- Invent Snoring Device
- Applicant
- Ventus Medical, Inc.
Hillsborough, CA, US - Received
- March 5, 2012
- Decision date
- June 12, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LWF – Dilator, Nasal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.3900
- Specialty
- Ear, Nose, Throat
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| K982929 | Maxair Nasal Dilator SystemLWF · Traditional | Hnl Technologies | 09/09/1998SE |
| K963326 | Breathe FitLWF · Traditional | Cambridge Assoc. | 02/12/1997SE |
| K962698 | Acutek's ClearpasageLWF · Traditional | Acutek Adhesive Specialties, Inc. | 09/09/1996SE |
| K962400 | Air Max External Nasal Dilator StripLWF · Traditional | American White Cross, Inc. | 09/09/1996SE |
| K955711 | Breathe Right Nasal StripLWF · Traditional | Cns, Inc. | 05/30/1996SE |
| K954914 | Breathe Right Nasal StripLWF · Traditional | Cns, Inc. | 02/27/1996SE |
| K955233 | Easy Breathing Nasal StripsLWF · Traditional | Corbett Lair, Inc. | 12/21/1995SE |
| K953042 | E-Z BreathersLWF · Traditional | E-Z Kare Good Health Systems, Inc. | 12/08/1995SE |
More from E-Z Kare Good Health Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K102404 | Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…OHP · Traditional | 12/02/2010SE |
| K090398 | Provent Professional Sleep Apnea TherapyOHP · Traditional | 04/03/2009SE |
| K080983 | Provent Nasal CannulaMNR · Traditional | 08/07/2008SE |
| K071560 | Provent Nasal Dilator, Model BR2OHP · Traditional | 02/08/2008SE |
Questions and answers
When was Invent Snoring Device cleared by the FDA?
Invent Snoring Device (K120665) received a 510(k) decision of Substantially Equivalent on June 12, 2012, 99 days after the submission was received.
What is the product code of K120665?
The FDA product code is LWF – Dilator, Nasal, a Class I (low risk) device regulated under 21 CFR 874.3900.