Swift Infant Oxygen Hood-Reusable (Modification)
FDA 510(k) K955482 · Advantage Medical Services, Inc.
510(k) numberK955482
Submission
- Device name
- Swift Infant Oxygen Hood-Reusable (Modification)
- Applicant
- Advantage Medical Services, Inc.
Edgerton, MO, US - Received
- November 1, 1995
- Decision date
- January 30, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K780220 | Hood, Infant OxygenFOG · Traditional | Shiley, Inc. | 04/10/1978SE |
| K770754 | Duodenoscope, Molel TX-6FOG · Traditional | American Cystocope Makers, Inc. | 04/28/1977SE |
Questions and answers
When was Swift Infant Oxygen Hood-Reusable (Modification) cleared by the FDA?
Swift Infant Oxygen Hood-Reusable (Modification) (K955482) received a 510(k) decision of Substantially Equivalent on January 30, 1996, 90 days after the submission was received.
What is the product code of K955482?
The FDA product code is FOG – Hood, Oxygen, Infant, a Class I (low risk) device regulated under 21 CFR 868.5700.