Company ยท US
Inovo, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2014. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 7, 2014 | K141967 | PUREFILL OXYGEN COMPRESSOR Inovo, Inc. | CAW |
| Dec 8, 2011 | K113111 | CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION Inovo, Inc. | NFB |
| Dec 17, 2010 | K103392 | CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER Inovo, Inc. | NFB |
| Jul 18, 2006 | K060751 | INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR Inovo, Inc. | NFB |
| Sep 21, 2005 | K051540 | INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR Inovo, Inc. | NFB |
| Sep 15, 2003 | K031983 | INOVO, INC, ECONOMIZER CONSERVING REGULATOR Inovo, Inc. | NFB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2019 | Inovo, Inc Inovo Single Luman Conserver
Product Usage:
This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales, resulting in greater efficiency Terminated |
NFB | K060751 |
| Oct 9, 2017 | Inovo, Inc PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S Terminated |
CAW | K080391 |
| Jul 21, 2016 | Inovo, Inc INOVO Purefill Oxygen Compressor Model PF1100
Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders. Terminated |
CAW | K141967 |