Company
Salter Laboratories, Division of Regulatory Affairs
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 26, 2011 | Salter Laboratories, Division of Regulatory Affairs Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs;
Salter Labs, Arvin, CA 93203
Intended usage: respiratory therapy. Terminated |
BYF | K772127 |
| Oct 26, 2011 | Salter Laboratories, Division of Regulatory Affairs Mask adult, oxygen, medium concentration, elastic strap style, w/9' tube - 50/cs;
Salter Labs, Arvin, CA 93203
Intended usage: respiratory therapy. Terminated |
BYG | None listed |
| Oct 26, 2011 | Salter Laboratories, Division of Regulatory Affairs Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w/9' tube and safety vent - 50/cs;
Mask adult, oxygen, high concentration, non-rebreathing, elastic strap style, w safety Terminated |
BYG | None listed |
| Oct 26, 2011 | Salter Laboratories, Division of Regulatory Affairs Mask adult, oxygen, medium concentration, elastic strap style w. 7' tube (Linde) 50/cs
Mask, adult, oxygen, high concentration, non-rebreathing, elastic strap style w/ 7' tube and safety vent - 50/c Terminated |
BYG | None listed |
| Oct 26, 2011 | Salter Laboratories, Division of Regulatory Affairs Nebulizer (adult elastic strap style aerosol mask 7' tube - 50/cs), Latex Free
Salter Labs, Arvin, CA 93203
Intended usage: respiratory therapy. Terminated |
CCQ | K870027 |
| May 23, 2011 | Salter Laboratories, Division of Regulatory Affairs Salter Labs Nasal Cannula (Adult) Salter Style with 14' (4.3) supply tube.
Single Patient use. Do not sterilize.
Used to deliver supplemental oxygen or airflow to a patient or person in need of respi Terminated |
CCK | None listed |
| May 20, 2011 | Salter Laboratories, Division of Regulatory Affairs Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sample tube with male luer connector 22mm (I.D) x 6mm (O.D) Adaptor. Adult Divided Cannula.
Single Patien Terminated |
CCK | K892406 |
| Feb 3, 2011 | Salter Laboratories, Division of Regulatory Affairs ThermiSense model 5700-A5
The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via Terminated |
BZQ | K080922 |