Castle Model 3341 & 3441 & 4141 Gas Aer
FDA 510(k) K831595 · Castle Co.
510(k) numberK831595
Submission
- Device name
- Castle Model 3341 & 3441 & 4141 Gas Aer
- Applicant
- Castle Co.
Mchenry, IL, US - Received
- May 17, 1983
- Decision date
- June 15, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FLI – Cabinet, Ethylene-Oxide Gas Aerator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6100
- Specialty
- General Hospital
Other 510(k)s with product code FLI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K904921 | Steri-Vac(Tm) Aerator Model XLFLI · Traditional | 3M Health Care, Ltd. | 12/05/1990SE |
| K902906 | Gas-Vak(R) Combination Sterilizer & VentilatorFLI · Traditional | Gas-Vak | 10/15/1990SE |
| K830165 | Bear Jet 150 VentilatorFLI · Traditional | Bear Medical Systems, Inc. | 04/12/1983SE |
| K813201 | Castle #3241 Gas AeratorFLI · Traditional | Sybron Corp. | 12/31/1981SE |
| K790677 | Eo Evacuating System IFLI · Traditional | Castle Co. | 05/07/1979SE |
| K781484 | Castle Model 3146 Gas AeratorFLI · Traditional | Castle Co. | 10/27/1978SE |
| K761341 | Portagas AeratorFLI · Traditional | Amsco Co. | 02/28/1977SE |
More from Amsco Co.
| 510(k) | Device | Decision |
|---|---|---|
| K870975 | Modified Castle PowerclaveFLE · Traditional | 04/17/1987SE |
| K860263 | Castle 7538 Floor Loading WasherLDS · Traditional | 03/05/1986SE |
| K844089 | Castle 7515 Utensil/Glassware WasherLDS · Traditional | 01/14/1985SE |
| K834048 | Bovie Conductive Adhes-Disper-ElectroGEI · Traditional | 04/04/1984SE |
| K833074 | Castle Tec-Test S.M.A.R.T. PackJOJ · Traditional | 11/07/1983SE |
| K792660 | 1500 Eo Exhaust HoodFLF · Traditional | 01/29/1980SE |
| K792649 | Unispore-Biological IndicatorsFRC · Traditional | 01/29/1980SE |
| K790677 | Eo Evacuating System IFLI · Traditional | 05/07/1979SE |
| K781887 | 9100 Daystar and 9110 Orbiter PackageFSY · Traditional | 12/12/1978SE |
| K781484 | Castle Model 3146 Gas AeratorFLI · Traditional | 10/27/1978SE |
Questions and answers
When was Castle Model 3341 & 3441 & 4141 Gas Aer cleared by the FDA?
Castle Model 3341 & 3441 & 4141 Gas Aer (K831595) received a 510(k) decision of Substantially Equivalent on June 15, 1983, 29 days after the submission was received.
What is the product code of K831595?
The FDA product code is FLI – Cabinet, Ethylene-Oxide Gas Aerator, a Class II (moderate risk) device regulated under 21 CFR 880.6100.