M-1 Pressure Monitor
FDA 510(k) K871336 · Bio-Med Devices, Inc.
510(k) numberK871336
Submission
- Device name
- M-1 Pressure Monitor
- Applicant
- Bio-Med Devices, Inc.
Madison, CT, US - Received
- April 3, 1987
- Decision date
- June 5, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAP – Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2600
- Specialty
- Anesthesiology
Other 510(k)s with product code CAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201666 | Single Use ManometerCAP · Traditional | Flexicare Medical Limited. | 11/13/2020SE |
| K182292 | VORTRAN APM-PlusCAP · Traditional | Vortran Medical Technology 1, Inc. | 09/18/2019SE |
| K180510 | NS 120P-TRS Airway Pressure GaugeCAP · Traditional | Instrumentation Industries, Inc. | 05/01/2019SE |
| K172284 | NAPA LP-15 Airway Pressure MonitorCAP · Traditional | Drw Medical, LLC | 02/09/2018SE |
| K153733 | VORTRAN ManometerCAP · Traditional | Vortran Medical Technology 1, Inc. | 09/16/2016SE |
| K143148 | Disposable Pressure Manometer (DPM)CAP · Traditional | Westmed, Inc. | 08/11/2015SE |
| K140370 | Disposable Pressure ManometerCAP · Traditional | Besmed Health Business Corp | 06/19/2014SE |
| K122627 | Gio Digital Pressure GuagesCAP · Traditional | Galemed Corp. | 08/22/2013SE |
| K122077 | ManometerCAP · Traditional | Intersurgical, Inc. | 01/10/2013SE |
| K120118 | Ventlab Pressurechek Disosable Column ManometerCAP · Traditional | Ventlab Corp. | 05/24/2012SE |
More from Ventlab Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K213948 | OxyMinderCCL · Traditional | 03/17/2022SE |
| K173973 | TV-100CBK · Traditional | 07/20/2018SE |
| K942938 | CROSSVENT-4 VentilatorCBK · Traditional | 09/19/1995ST |
| K896381 | MVP-10 MRI Infant VentilatorCBK · Traditional | 02/12/1990SE |
| K896380 | IC-2A MRI Adult/Pediatric VentilatorCBK · Traditional | 02/12/1990SE |
| K873614 | CBG Cuff ManometerBSK · Traditional | 01/22/1988SE |
| K871337 | M-2 Oxygen/Temperature MonitorCCL · Traditional | 06/05/1987SE |
| K871139 | M-10 Ventilation MonitorCAP · Traditional | 04/21/1987SE |
| K830230 | Programmable VentilatorCBK · Traditional | 02/09/1983SE |
| K823861 | ET-3 Emergency Transport VentilatorCBK · Traditional | 02/07/1983SE |
Questions and answers
When was M-1 Pressure Monitor cleared by the FDA?
M-1 Pressure Monitor (K871336) received a 510(k) decision of Substantially Equivalent on June 5, 1987, 63 days after the submission was received.
What is the product code of K871336?
The FDA product code is CAP – Monitor, Airway Pressure (Includes Gauge And/Or Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.2600.