510(k) K913164 ยท KGB Mask, Oxygen, Non-Rebreathing
NON REBREATHING MASK
| Applicant | Specialty Packaging Producs, Inc., El Paso TX, US |
| Decision | Substantially Equivalent, Jan 15, 1992 |
| Received | Jul 17, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913164
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2020 | Westmed, Inc. REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, Rx Only, CE0482, (01)00709078003172 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy Terminated |
KGB | None listed |
| Nov 11, 2020 | Westmed, Inc. Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to th Terminated |
KGB | None listed |
| Nov 11, 2020 | Westmed, Inc. REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE0482, (01)00709078005718 - Product Usage: intended to Terminated |
KGB | None listed |
| Nov 11, 2020 | Westmed, Inc. REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter, Rx Only, CE0482, (01)00709078005664 - Product Usage: inte Terminated |
KGB | None listed |
| Nov 11, 2020 | Westmed, Inc. REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient. Terminated |
KGB | None listed |
| Nov 11, 2020 | Westmed, Inc. REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Only, CE0482, (01)00709078001697 - Product Usage: intended to conn Terminated |
KGB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.