Bear 7 Ventilator
FDA 510(k) K912619 · Bear Medical Systems, Inc.
510(k) numberK912619
Submission
- Device name
- Bear 7 Ventilator
- Applicant
- Bear Medical Systems, Inc.
Riverside, CA, US - Received
- June 13, 1991
- Decision date
- June 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K251133 | AVEA disposable expiratory filter/water trap (11790)CBK · Traditional | Telesair, Inc. | 05/08/2025SE |
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| K233486 | 731 Series VentilatorCBK · Traditional | ZOLL Medical Corporation | 12/13/2024SE |
| K223120 | Ventoux VC2; Ventoux VC3CBK · Traditional | Flight Medical Innovations , Ltd. | 12/02/2024SE |
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| K992788 | Bear Cub 750 PSVCBK · Special | 09/16/1999SE |
| K983981 | Bear 1000, Veolar W Leonardo Graphics, Bicore CP-2000, Bicore CP-100, Hi-Lo Jet Et TubeCBK · Special | 11/20/1998SE |
| K900637 | Bear Cem ControllerCBK · Traditional | 08/03/1990SE |
| K896315 | Bear VH820 Disposable Chamber AssemblyBTT · Traditional | 01/22/1990SE |
| K893034 | VHS 820 Humidifier, ModificationBTT · Traditional | 07/14/1989SE |
| 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 |
| K872660 | Bear NVM-1BZK · Traditional | 02/12/1988SE |
| K873634 | Bear VH-820 HumidifierBTT · Traditional | 12/02/1987SE |
Questions and answers
When was Bear 7 Ventilator cleared by the FDA?
Bear 7 Ventilator (K912619) received a 510(k) decision of Substantially Equivalent on June 11, 1992, 364 days after the submission was received.
What is the product code of K912619?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.