Ventilator Adaptor, #751
FDA 510(k) K770587 · Surgicot, Inc.
510(k) numberK770587
Submission
- Device name
- Ventilator Adaptor, #751
- Applicant
- Surgicot, Inc.
Mchenry, IL, US - Received
- March 28, 1977
- Decision date
- April 5, 1977
- 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 |
|---|---|---|
| K962605 | Pro-Guard Double-Duty Sterilization Wrap (Single Use)FRG · Traditional | 03/11/1997SE |
| K931270 | Surgiclean Enzymatic Instrument CleanerFLG · Traditional | 04/13/1994SE |
| K863122 | Assert Biological/Chemical Indicator 12 Month Exp.FRC · Traditional | 12/17/1986SE |
| K855101 | Assert TM Biological/Chemical IndicatorFRC · Traditional | 07/17/1986SE |
| K854631 | Assert Eo Biological Test PackFRC · Traditional | 05/27/1986SE |
| K854902 | Surgicot Steam Test PackFRC · Traditional | 05/20/1986SE |
| K840541 | Neuro SpongeGDY · Traditional | 04/23/1984SE |
| K840471 | Eye SpearHOZ · Traditional | 03/16/1984SE |
| K840470 | Surgiscribe Marking PenFZZ · Traditional | 03/12/1984SE |
| K830739 | Pro-GuardFRG · Traditional | 03/29/1983SE |
Questions and answers
When was Ventilator Adaptor, #751 cleared by the FDA?
Ventilator Adaptor, #751 (K770587) received a 510(k) decision of Substantially Equivalent on April 5, 1977, 8 days after the submission was received.
What is the product code of K770587?
The FDA product code is BZA – Connector, Airway (Extension), a Class I (low risk) device regulated under 21 CFR 868.5810.