Bear NICU-1
FDA 510(k) K853346 · Bear Medical Systems, Inc.
510(k) numberK853346
Submission
- Device name
- Bear NICU-1
- Applicant
- Bear Medical Systems, Inc.
Riverside, CA, US - Received
- August 12, 1985
- Decision date
- September 11, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZK – Spirometer, Monitoring (W/Wo Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1850
- Specialty
- Anesthesiology
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| K103578 | Philips NM3 Respiratory Monitor with VentassistBZK · Traditional | Respironics Novametrix, LLC | 06/02/2011SE |
| K091853 | Wright Respirometer, Mark 8, and 14 Respirometer, Model 700-021, 700-008, 700-014BZK · Traditional | Nspire Health, Inc. | 09/21/2009SE |
| K092217 | Mercury VCO2BZK · Special | Respironics Novametrix, Inc. | 08/21/2009SE |
More from Respironics Novametrix, Inc.
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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 |
| K912619 | Bear 7 VentilatorCBK · Traditional | 06/11/1992SE |
| 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 |
Questions and answers
When was Bear NICU-1 cleared by the FDA?
Bear NICU-1 (K853346) received a 510(k) decision of Substantially Equivalent on September 11, 1985, 30 days after the submission was received.
What is the product code of K853346?
The FDA product code is BZK – Spirometer, Monitoring (W/Wo Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.1850.