Double Lumen E T Adaptor
FDA 510(k) K862435 · Acutronic Medical Systems AG
510(k) numberK862435
Submission
- Device name
- Double Lumen E T Adaptor
- Applicant
- Acutronic Medical Systems AG
Jona-Rapper Swril, CH - Received
- June 26, 1986
- Decision date
- October 22, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZA – Connector, Airway (Extension)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5810
- Specialty
- Anesthesiology
Other 510(k)s with product code BZA
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|---|---|---|---|
| K083702 | Trach-AssistBZA · Traditional | Mergenet Medical | 03/05/2009SE |
| K954383 | Sureloc Circuit ConnectorBZA · Traditional | Polamedco, Inc. | 12/22/1995SE |
| K954197 | Disposable Flex TubeBZA · Traditional | Engstrom Medical | 10/26/1995SE |
| K953786 | Unicor, Inc. Connectors & Airway ExtensionsBZA · Traditional | Unicor, Inc. | 09/19/1995SE |
| K952824 | Neo-Link, Disposable Neonatal Air Way ConnectorBZA · Traditional | Intertex Medical, Inc. | 07/20/1995SE |
| K951345 | Disposable Airway Connectors for Gas SamplingBZA · Traditional | Catheter Research, Inc. | 04/14/1995SE |
| K944532 | Prima, Inc. Ventilator HosesBZA · Traditional | Prima, Inc. | 12/02/1994SE |
| K944535 | Prima, Inc. Gas Sampling Lines and ConnectorsBZA · Traditional | Prima, Inc. | 11/29/1994SE |
| K944534 | Prima, Inc. Connectors and Airway ExtensionsBZA · Traditional | Prima, Inc. | 11/29/1994SE |
| K942392 | Airway Connector with Flex TubeBZA · Traditional | Mallinckrodt Medical | 08/22/1994SE |
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| K900745 | VS-200S Jet VentilatorCBK · Traditional | 04/29/1991SE |
| K900744 | Ams 3000 Portable Jet VentilatorCBK · Traditional | 04/29/1991SE |
| K883865 | External Jet Synchronizer, Model AMS-1010CBK · Traditional | 06/08/1989SE |
| K863155 | Universal Jet Ventilator Model AMS-1000CBK · Traditional | 09/28/1987SE |
| K863154 | Heated Jet Humidifier Model AMS-1020BTT · Traditional | 01/12/1987SE |
| K862436 | Trans- Circothyrotomy Device (Acc. Ravussin)BTO · Traditional | 11/03/1986SE |
| K862433 | Uni-Jet ConnectorBZA · Traditional | 08/06/1986SE |
Questions and answers
When was Double Lumen E T Adaptor cleared by the FDA?
Double Lumen E T Adaptor (K862435) received a 510(k) decision of Substantially Equivalent on October 22, 1986, 118 days after the submission was received.
What is the product code of K862435?
The FDA product code is BZA – Connector, Airway (Extension), a Class I (low risk) device regulated under 21 CFR 868.5810.