Unicor, Inc. Connectors & Airway Extensions
FDA 510(k) K953786 · Unicor, Inc.
510(k) numberK953786
Submission
- Device name
- Unicor, Inc. Connectors & Airway Extensions
- Applicant
- Unicor, Inc.
Cleveland, TN, US - Received
- August 14, 1995
- Decision date
- September 19, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K941026 | Thayer Mask to Mouthpiece Adapter/ConnectorBZA · Traditional | Thayer Medical Corp. | 08/18/1994SE |
More from Thayer Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K953788 | Unicor, Inc. Gas Sampling Lines & ConnectorsCAI · Traditional | 09/19/1995SE |
| K953787 | Unicor, Inc. Adult Anesthesia Breathing CircuitCAI · Traditional | 09/19/1995SE |
| K953784 | Unicor, Inc. Corrugated TubingBZO · Traditional | 09/19/1995SE |
| K953785 | Unicor, Inc. Ventilator HosesBZO · Traditional | 09/18/1995SE |
Questions and answers
When was Unicor, Inc. Connectors & Airway Extensions cleared by the FDA?
Unicor, Inc. Connectors & Airway Extensions (K953786) received a 510(k) decision of Substantially Equivalent on September 19, 1995, 36 days after the submission was received.
What is the product code of K953786?
The FDA product code is BZA – Connector, Airway (Extension), a Class I (low risk) device regulated under 21 CFR 868.5810.