Bear Jet 150 Ventilator
FDA 510(k) K830165 · Bear Medical Systems, Inc.
510(k) numberK830165
Submission
- Device name
- Bear Jet 150 Ventilator
- Applicant
- Bear Medical Systems, Inc.
Walker, MI, US - Received
- January 18, 1983
- Decision date
- April 12, 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 |
| K831595 | Castle Model 3341 & 3441 & 4141 Gas AerFLI · Traditional | Castle Co. | 06/15/1983SE |
| 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 |
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| K900637 | Bear Cem ControllerCBK · Traditional | 08/03/1990SE |
| K896315 | Bear VH820 Disposable Chamber AssemblyBTT · Traditional | 01/22/1990SE |
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| K890724 | Mofification Bear NVM-1 Neonatal Volume MonitorBZK · Traditional | 03/30/1989SE |
| K882764 | Bear EVC-100 ControllerCBK · Traditional | 09/30/1988SE |
| K881335 | Bear 3 VentilatorCBK · Traditional | 08/04/1988SE |
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Questions and answers
When was Bear Jet 150 Ventilator cleared by the FDA?
Bear Jet 150 Ventilator (K830165) received a 510(k) decision of Substantially Equivalent on April 12, 1983, 84 days after the submission was received.
What is the product code of K830165?
The FDA product code is FLI – Cabinet, Ethylene-Oxide Gas Aerator, a Class II (moderate risk) device regulated under 21 CFR 880.6100.