Collins Digital Pulmonary Manometer
FDA 510(k) K912946 · Warren E. Collins, Inc.
510(k) numberK912946
Submission
- Device name
- Collins Digital Pulmonary Manometer
- Applicant
- Warren E. Collins, Inc.
Braintree, MA, US - Received
- July 5, 1991
- Decision date
- January 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K904917 | Thayer Mip AdapterBXR · Traditional | Thayer Medical Corp. | 01/28/1991SE |
| 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 |
|---|---|---|
| K925459 | Gs-Modular (Gold Standard - Modular)BZG · Traditional | 02/04/1994SE |
| K871151 | The Spira Elektro 2CCQ · Traditional | 05/15/1987SE |
| K861227 | Collins Pneumotach PFT SystemBZG · Traditional | 06/05/1986SE |
| K852102 | Collin Body Plethysmograph Plus SystemCCM · Traditional | 07/31/1985SE |
| K831780 | Metabolic Exercise Testing SystemBZL · Traditional | 09/12/1983SE |
| K831778 | Rs-Residual Volume SystemBZC · Traditional | 08/31/1983SE |
| K831777 | Collins DSBZC · Traditional | 08/31/1983SE |
| K831779 | Collins Eagle IIBZC · Traditional | 08/26/1983SE |
| K803069 | Shell Kraton Thermo-Plastic Rubber Comp.BYP · Traditional | 12/22/1980SE |
| K803053 | Apexline of Pulmonary Funct. Instrum.BTY · Traditional | 12/22/1980SE |
Questions and answers
When was Collins Digital Pulmonary Manometer cleared by the FDA?
Collins Digital Pulmonary Manometer (K912946) received a 510(k) decision of Substantially Equivalent on January 15, 1992, 194 days after the submission was received.
What is the product code of K912946?
The FDA product code is BXR – Meter, Airway Pressure (Inspiratory Force), a Class II (moderate risk) device regulated under 21 CFR 868.1780.