Micro MPM
FDA 510(k) K940375 · Micro Direct, Inc.
510(k) numberK940375
Submission
- Device name
- Micro MPM
- Applicant
- Micro Direct, Inc.
Auburn, ME, US - Received
- January 26, 1994
- Decision date
- November 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K033688 | Micro H2 Breath Monitoring Device with Hydra Software UtilityNRH · Traditional | 05/19/2004SE |
| K031102 | Microlab SpirometerBZG · Traditional | 12/01/2003SE |
| K030586 | MicropeakBZH · Traditional | 08/27/2003SE |
| K973314 | Spirosafe FilterCAH · Traditional | 11/21/1997SE |
| K965042 | Microdl Diarycard SpirometerBZG · Traditional | 06/17/1997SE |
| K963376 | Micro H2NRH · Traditional | 01/24/1997SE |
| K963035 | Micro SpirometerBZG · Traditional | 11/01/1996SE |
| K950197 | MicrocoCCJ · Traditional | 10/17/1996SE |
Questions and answers
When was Micro MPM cleared by the FDA?
Micro MPM (K940375) received a 510(k) decision of Substantially Equivalent on November 21, 1994, 299 days after the submission was received.
What is the product code of K940375?
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.