Hood, Infant Oxygen
FDA 510(k) K780220 · Shiley, Inc.
510(k) numberK780220
Submission
- Device name
- Hood, Infant Oxygen
- Applicant
- Shiley, Inc.
Mchenry, IL, US - Received
- February 10, 1978
- Decision date
- April 10, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FOG – Hood, Oxygen, Infant
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5700
- Specialty
- Anesthesiology
Other 510(k)s with product code FOG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973128 | Olympus NA-10J-1 Aspiration NeedleFOG · Traditional | Olympus America, Inc. | 11/18/1997SE |
| K962182 | Burlew Infant HoodFOG · Traditional | Promedic, Inc. | 07/15/1996SE |
| K955482 | Swift Infant Oxygen Hood-Reusable (Modification)FOG · Traditional | Advantage Medical Services, Inc. | 01/30/1996SE |
| K830781 | Endo-GuardFOG · Traditional | Jayco Pharmaceuticals | 03/31/1983SE |
| K792144 | Disposa-HoodFOG · Traditional | Utah Medical Products, Inc. | 12/05/1979SE |
| K791861 | Oxygen HoodsFOG · Traditional | Ann Arbor Plastics, Inc. | 10/04/1979SE |
| K790860 | Rt-HoodFOG · Traditional | Plastics Supplies & Products | 05/29/1979SE |
| K770754 | Duodenoscope, Molel TX-6FOG · Traditional | American Cystocope Makers, Inc. | 04/28/1977SE |
More from American Cystocope Makers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K920594 | Shiley Perfusion Tubing SetsDTM · Traditional | 03/18/1993SE |
| K910991 | Shiley Therapeutic Autotransfusion SystemCAC · Traditional | 11/27/1991SE |
| K911876 | Shiley Plexus(R) Venous Reservoir, PVR1200DTN · Traditional | 08/09/1991SE |
| K910923 | BCD AdvancedDTR · Traditional | 04/09/1991SE |
| K901548 | Biomedical Sensors-Shiley BGM 4000 Intra Blood GasCCC · Traditional | 01/14/1991SE |
| K903435 | Shiley Specialized Tracheostomy TubeJOH · Traditional | 10/02/1990SE |
| K901624 | Shiley Plexus Integral Reservoir Hollow Fiber Oxy.DTZ · Traditional | 07/03/1990SE |
| K901250 | Plexus 2(TM) Infant Hollow Fiber OxygenatorDTZ · Traditional | 06/11/1990SE |
| K901249 | Plexus 3.5(TM) Pediatric Hollow Fiber OxygenatorDTZ · Traditional | 06/11/1990SE |
| K900797 | Stockert Shiley Dual Pressure Control Module XRDXS · Traditional | 05/10/1990SE |
Questions and answers
When was Hood, Infant Oxygen cleared by the FDA?
Hood, Infant Oxygen (K780220) received a 510(k) decision of Substantially Equivalent on April 10, 1978, 59 days after the submission was received.
What is the product code of K780220?
The FDA product code is FOG – Hood, Oxygen, Infant, a Class I (low risk) device regulated under 21 CFR 868.5700.