NON REBREATHING MASK— 510(k) K913164
Substantially EquivalentSpecialty Packaging Producs, Inc.
FDA 510(k) clearance K913164 for NON REBREATHING MASK, Substantially Equivalent on 1992-01-15. Applicant: Specialty Packaging Producs, Inc.. Device class: 1.
Clearance details
- Applicant
- Specialty Packaging Producs, Inc.
- Product code
- Code KGB
- Device class
- Class 1
- Regulation
- 21 CFR 868.5570
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- El Paso, TX, US
Recent devices under product code KGB
view allMore clearances from Specialty Packaging Producs, Inc.
view allRecalls naming K913164
K-number listed on FDA's recall record- Z-0741-2021 — 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 to the patient.
- Z-0742-2021 — 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 the patient.
- Z-0743-2021 — 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 connect with an oxygen source to deliver oxygen therapy to the patient.
- Z-0744-2021 — 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: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
- Z-0745-2021 — REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
- Z-0746-2021 — 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 connect with an oxygen source to deliver oxygen therapy to the patient.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K913164.
Data sourced from openFDA. This site is unofficial and independent of the FDA.