Disposable Pressure Manometer (DPM)
FDA 510(k) K143148 · Westmed, Inc.
510(k) numberK143148
Submission
- Device name
- Disposable Pressure Manometer (DPM)
- Applicant
- Westmed, Inc.
Tucson, AZ, US - Received
- November 3, 2014
- Decision date
- August 11, 2015
- 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 |
| 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 |
| 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 |
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|---|---|---|
| K162343 | Westmed Gas Sampling Cannula with O2 deliveryCCK · Traditional | 12/14/2016SE |
| K133057 | Vibralung Acoustical PercussorSDT · Traditional | 05/23/2014SE |
| K121382 | Westmed, Inc.'s Blockaide Filter [21 CFR 807.87(A)]CAH · Traditional | 12/06/2012SE |
| K081905 | Accuflow and Accuflux Elastomeric Infusion PumpMEB · Traditional | 07/15/2008SE |
| K072220 | Pedi CO2 EasyCCK · Traditional | 08/23/2007SE |
| K070128 | CO2 EasyCCK · Traditional | 02/15/2007SE |
| K953464 | Westmed Pediatric & Adult Medium Concentration Oxygen MaskBYG · Traditional | 09/18/1995SE |
Questions and answers
When was Disposable Pressure Manometer (DPM) cleared by the FDA?
Disposable Pressure Manometer (DPM) (K143148) received a 510(k) decision of Substantially Equivalent on August 11, 2015, 281 days after the submission was received.
What is the product code of K143148?
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.