NAPA LP-15 Airway Pressure Monitor
FDA 510(k) K172284 · Drw Medical, LLC
510(k) numberK172284
Submission
- Device name
- NAPA LP-15 Airway Pressure Monitor
- Applicant
- Drw Medical, LLC
Brookhaven, PA, US - Received
- July 28, 2017
- Decision date
- February 9, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K103639 | Vortran Airway Pressure Monitor (Vapm)-Adult, Vortran Airway Pressure Monitor (Vapm)-…CAP · Traditional | Vortran Medical Technology 1, Inc. | 09/15/2011SE |
More from Vortran Medical Technology 1, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K221676 | ExsaltaBTA · Traditional | 09/16/2022SE |
Questions and answers
When was NAPA LP-15 Airway Pressure Monitor cleared by the FDA?
NAPA LP-15 Airway Pressure Monitor (K172284) received a 510(k) decision of Substantially Equivalent on February 9, 2018, 196 days after the submission was received.
What is the product code of K172284?
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.