Bear VH820 Disposable Chamber Assembly
FDA 510(k) K896315 · Bear Medical Systems, Inc.
510(k) numberK896315
Submission
- Device name
- Bear VH820 Disposable Chamber Assembly
- Applicant
- Bear Medical Systems, Inc.
Riverside, CA, US - Received
- November 1, 1989
- Decision date
- January 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5450
- Specialty
- Anesthesiology
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| K900637 | Bear Cem ControllerCBK · Traditional | 08/03/1990SE |
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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 |
| K872660 | Bear NVM-1BZK · Traditional | 02/12/1988SE |
| K873634 | Bear VH-820 HumidifierBTT · Traditional | 12/02/1987SE |
Questions and answers
When was Bear VH820 Disposable Chamber Assembly cleared by the FDA?
Bear VH820 Disposable Chamber Assembly (K896315) received a 510(k) decision of Substantially Equivalent on January 22, 1990, 82 days after the submission was received.
What is the product code of K896315?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.