Circuit, Breathing (W/ Connector, Adapt,
FDA 510(k) K792047 · Airlife, Inc.
510(k) numberK792047
Submission
- Device name
- Circuit, Breathing (W/ Connector, Adapt,
- Applicant
- Airlife, Inc.
Walker, MI, US - Received
- October 12, 1979
- Decision date
- October 30, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZO – Set, Tubing And Support, Ventilator (W Harness)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5975
- Specialty
- Anesthesiology
Other 510(k)s with product code BZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K953784 | Unicor, Inc. Corrugated TubingBZO · Traditional | Unicor, Inc. | 09/19/1995SE |
| K953785 | Unicor, Inc. Ventilator HosesBZO · Traditional | Unicor, Inc. | 09/18/1995SE |
| K952022 | Prima Volumn VentilatorssBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K952012 | Prima Custom Anestesia CircuitBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K952011 | Prima Breathing BagsBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K952010 | Prima Ventilator HosesBZO · Traditional | Prima, Inc. | 05/22/1995SE |
| K945740 | Infant Flow SystemBZO · Traditional | Hamilton Medical, Inc. | 03/23/1995SE |
| K944531 | Prima, Inc. Corrugated TubingBZO · Traditional | Prima, Inc. | 12/02/1994SE |
| K942572 | Volume VentilatorBZO · Traditional | Med-Plastics Intl., Inc. | 06/10/1994SE |
| K942569 | Ventilator HoseBZO · Traditional | Med-Plastics Intl., Inc. | 06/10/1994SE |
More from Med-Plastics Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K834573 | Aqua TrapBYH · Traditional | 03/05/1984SE |
| K834570 | Volume Ventilator Circuit W/Water TrapBZO · Traditional | 03/05/1984SE |
| K834077 | Single Use Nebulizer-Adjust-Air EntrainCAF · Traditional | 12/12/1983SE |
| K833196 | Volume Ventilator Circuit-NebulizerCAI · Traditional | 11/03/1983SE |
| K833197 | Trach Swive/ConnectorBTR · Traditional | 10/28/1983SE |
| K832725 | Dual Dial Venturi Style MaskBYF · Traditional | 09/20/1983SE |
| K831246 | Whistler In-Line Pressure Release ValveCBP · Traditional | 07/26/1983SE |
| K830895 | Single Use Nebulizer, Adjust. Air-CAF · Traditional | 04/28/1983SE |
| K830896 | Humidifier, with or Without AdapterKFZ · Traditional | 04/18/1983SE |
| K821129 | Airlife Nebulizer HeaterCAF · Traditional | 05/18/1982SE |
Questions and answers
When was Circuit, Breathing (W/ Connector, Adapt, cleared by the FDA?
Circuit, Breathing (W/ Connector, Adapt, (K792047) received a 510(k) decision of Substantially Equivalent on October 30, 1979, 18 days after the submission was received.
What is the product code of K792047?
The FDA product code is BZO – Set, Tubing And Support, Ventilator (W Harness), a Class I (low risk) device regulated under 21 CFR 868.5975.