Company ยท CA
Embla Systems
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2019. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 27, 2019 | K180001 | Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable Embla Systems, CA | MNR |
| Mar 1, 2019 | K173793 | XactTrace Single Use Respiratory Effort Belt System Embla Systems, CA | MNR |
| Nov 13, 2017 | K172703 | Disposable Snap Electrode Embla Systems, CA | GXY |
| Apr 11, 2017 | K163617 | REMbrandt Embla Systems, CA | OLZ |
| Dec 1, 2016 | K162140 | RemLogic Embla Systems, CA | OLZ |
| Jun 23, 2016 | K153353 | SANDMAN ELITE Embla Systems, CA | OLZ |
| Feb 21, 2013 | K122516 | EMBLETTA MPR Embla Systems, CA | MNR |
| Aug 31, 2011 | K111742 | MDRIVE Embla Systems | MNR |
| Aug 8, 2008 | K073682 | EMBLETTA GOLD Embla Systems, Inc. | MNR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||