Disposa-Hood
FDA 510(k) K792144 · Utah Medical Products, Inc.
510(k) numberK792144
Submission
- Device name
- Disposa-Hood
- Applicant
- Utah Medical Products, Inc.
Mchenry, IL, US - Received
- October 23, 1979
- Decision date
- December 5, 1979
- 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 |
| 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 |
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| K965245 | TBDHGI · Traditional | 07/03/1997SE |
| K970077 | Liberty Plus SYSTEM(PFS-300)/VAGINAL Probe, Liberty PLUS(PFS-044)KPI · Traditional | 05/23/1997SE |
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Questions and answers
When was Disposa-Hood cleared by the FDA?
Disposa-Hood (K792144) received a 510(k) decision of Substantially Equivalent on December 5, 1979, 43 days after the submission was received.
What is the product code of K792144?
The FDA product code is FOG – Hood, Oxygen, Infant, a Class I (low risk) device regulated under 21 CFR 868.5700.