Neotech Universal Adapter
FDA 510(k) K882203 · Neotech Products, Inc.
510(k) numberK882203
Submission
- Device name
- Neotech Universal Adapter
- Applicant
- Neotech Products, Inc.
Chatsworth, CA, US - Received
- May 25, 1988
- Decision date
- June 17, 1988
- 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 |
|---|---|---|
| K011564 | NeoleadDRX · Traditional | 01/03/2002SE |
| K931727 | Urinary Drainage Bag CaddyFAQ · Traditional | 07/23/1993SE |
| K921024 | Uro-Tote Leg BagKNX · Traditional | 09/02/1992SE |
| K890425 | Neotech Mucus Trap W/CatheterBSY · Traditional | 04/19/1989SE |
| K880487 | Neotech Meconium Aspirator (Sterile)BTR · Traditional | 05/06/1988SE |
Questions and answers
When was Neotech Universal Adapter cleared by the FDA?
Neotech Universal Adapter (K882203) received a 510(k) decision of Substantially Equivalent on June 17, 1988, 23 days after the submission was received.
What is the product code of K882203?
The FDA product code is BZA – Connector, Airway (Extension), a Class I (low risk) device regulated under 21 CFR 868.5810.