Gas-Vak(R) Combination Sterilizer & Ventilator
FDA 510(k) K902906 · Gas-Vak
510(k) numberK902906
Submission
- Device name
- Gas-Vak(R) Combination Sterilizer & Ventilator
- Applicant
- Gas-Vak
Westwood, CA, US - Received
- July 3, 1990
- Decision date
- October 15, 1990
- 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 |
| K831595 | Castle Model 3341 & 3441 & 4141 Gas AerFLI · Traditional | Castle Co. | 06/15/1983SE |
| 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 |
|---|---|---|
| K890438 | Gas-Vak(R), Model 300CBN · Traditional | 08/07/1989SE |
Questions and answers
When was Gas-Vak(R) Combination Sterilizer & Ventilator cleared by the FDA?
Gas-Vak(R) Combination Sterilizer & Ventilator (K902906) received a 510(k) decision of Substantially Equivalent on October 15, 1990, 104 days after the submission was received.
What is the product code of K902906?
The FDA product code is FLI – Cabinet, Ethylene-Oxide Gas Aerator, a Class II (moderate risk) device regulated under 21 CFR 880.6100.