Bodia Bronch-Saf Double Swivel
FDA 510(k) K833373 · Sontek Industries, Inc.
510(k) numberK833373
Submission
- Device name
- Bodia Bronch-Saf Double Swivel
- Applicant
- Sontek Industries, Inc.
Mchenry, IL, US - Received
- September 27, 1983
- Decision date
- November 3, 1983
- 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
| 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 |
| 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 |
More from Mallinckrodt Medical
| 510(k) | Device | Decision |
|---|---|---|
| K833374 | Bite-BlockJAY · Traditional | 11/03/1983SE |
| K833372 | Bodia Trach-Saf Double SwivelBZA · Traditional | 11/03/1983SE |
| K833361 | Tube-TitleJAY · Traditional | 11/03/1983SE |
| K813324 | Bodai Swivel YBSY · Traditional | 12/29/1981SE |
| K812720 | Bodai Patient CommunicatorILQ · Traditional | 11/05/1981SE |
| K811241 | Bodai Suction -Safe 4BSY · Traditional | 05/27/1981SE |
Questions and answers
When was Bodia Bronch-Saf Double Swivel cleared by the FDA?
Bodia Bronch-Saf Double Swivel (K833373) received a 510(k) decision of Substantially Equivalent on November 3, 1983, 37 days after the submission was received.
What is the product code of K833373?
The FDA product code is BZA – Connector, Airway (Extension), a Class I (low risk) device regulated under 21 CFR 868.5810.