Thayer Mip Adapter
FDA 510(k) K904917 · Thayer Medical Corp.
510(k) numberK904917
Submission
- Device name
- Thayer Mip Adapter
- Applicant
- Thayer Medical Corp.
Tucson, AZ, US - Received
- October 31, 1990
- Decision date
- January 28, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BXR – Meter, Airway Pressure (Inspiratory Force)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1780
- Specialty
- Anesthesiology
Other 510(k)s with product code BXR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K081693 | NS Series Nif (Negative Inspiratory Force) MetersBXR · Traditional | Instrumentation Industries, Inc. | 09/11/2008SE |
| K032593 | Mercury Medical Negative Inspiratory Force (Nif) Disposable MonometerBXR · Traditional | Mercury Medical | 02/03/2004SE |
| K912946 | Collins Digital Pulmonary ManometerBXR · Traditional | Warren E. Collins, Inc. | 01/15/1992SE |
| K901998 | Digital Manometer (DM 50)BXR · Traditional | Medical Support Products, Inc. | 07/25/1990SE |
| K873498 | Inspiratory Force Mont Kit/Manifold/Meter/TubingBXR · Traditional | Dhd Medical Products Div. Diemolding Corp. | 03/09/1988SE |
More from Dhd Medical Products Div. Diemolding Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterCAF · Special | 06/18/2024SE |
| K210558 | LiteAire Basic Dual-Valved, Collapsible MDI Holding ChamberNVP · Traditional | 04/01/2022SE |
| K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding ChamberNVP · Traditional | 05/19/2017SE |
| K111570 | Minispacer(R) Mdi Adapter with Counter Incrementing ActuatorCAF · Traditional | 09/29/2011SE |
| K102658 | Minispacer Dual-Spray Mdi Adapter with 22MM (or 15MM) Od / 22MM Od/Id Connections / 15MM…CAF · Special | 12/10/2010SE |
| K993101 | LiteaireCAF · Traditional | 10/26/2000SE |
| K992722 | PrimeaireCAF · Traditional | 11/10/1999SE |
| K972237 | Hand Held MedispacerCAF · Traditional | 07/31/1997SE |
| K955805 | Dual Spray MinispacerCAF · Traditional | 03/21/1996SE |
| K941026 | Thayer Mask to Mouthpiece Adapter/ConnectorBZA · Traditional | 08/18/1994SE |
Questions and answers
When was Thayer Mip Adapter cleared by the FDA?
Thayer Mip Adapter (K904917) received a 510(k) decision of Substantially Equivalent on January 28, 1991, 89 days after the submission was received.
What is the product code of K904917?
The FDA product code is BXR – Meter, Airway Pressure (Inspiratory Force), a Class II (moderate risk) device regulated under 21 CFR 868.1780.