Continuous, Ventilator, Home Use
The continuous home-use ventilator is an anesthesiology device designed to provide mechanical ventilation to patients requiring ongoing respiratory support in a home care setting. It is classified as FDA Class 2 under regulation 868.5895 in the Anesthesiology specialty, requiring 510(k) clearance, and carries a life-sustaining flag indicating its critical role in patient survival. Unlike the non-tracked CBK product code, NOU is subject to device tracking requirements. Product code NOU is not eligible for third-party review.
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Basic Information
- Product Code
- NOU
- Device Class
- FDA class 2
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
Definition
This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233452 | Vivo 45 LS | Jan 13, 2025 | Substantially Equivalent | Breas Medical AB |
| K193586 | Vivo 45 LS | Jan 27, 2021 | Substantially Equivalent | Breas Medical AB |
| K160481 | Vivo 60 | Nov 09, 2016 | Substantially Equivalent | Breas Medical AB |
| K123144 | VIVO 50 | Jun 18, 2013 | Substantially Equivalent | Ge Healthcare, Breas Medical AB |
| K034032 | PLV CONTINUUM VENTILATOR, MODEL P2000 | Mar 16, 2004 | Substantially Equivalent | Respironics California, Inc. |
| K022750 | PLV CONTINUUM VENTILATOR, MODEL P1000 | Nov 20, 2003 | Substantially Equivalent | Respironics California, Inc. |
| K021981 | IVENT 201 PORTABLE VENTILATOR | Aug 13, 2003 | Substantially Equivalent | Versamed , Ltd. |
FEI Numbers
This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.