Company ยท US
Inovel, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2007. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MSH | Respirator, Surgical | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 12, 2007 | K063747 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A Inovel, LLC | MSH |
| Oct 24, 2006 | K062665 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS Inovel, LLC | MSH |
| Jul 12, 2006 | K061859 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS Inovel, LLC | MSH |
| May 19, 2005 | K051182 | INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS Inovel, LLC | MSH |
| Sep 30, 2004 | K042267 | INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP Inovel, LLC | MSH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2009 | Inovel LLC Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010. Terminated |
MSH | K042267 |
| Mar 3, 2006 | Inovel LLC Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number(s): 3002N95-M, Lot Number 051130-161. Terminated |
MSH | K051182 |