Gio Digital Pressure Guages
FDA 510(k) K122627 · Galemed Corp.
510(k) numberK122627
Submission
- Device name
- Gio Digital Pressure Guages
- Applicant
- Galemed Corp.
Temecula, CA, US - Received
- August 28, 2012
- Decision date
- August 22, 2013
- 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 |
| K143148 | Disposable Pressure Manometer (DPM)CAP · Traditional | Westmed, Inc. | 08/11/2015SE |
| K140370 | Disposable Pressure ManometerCAP · Traditional | Besmed Health Business Corp | 06/19/2014SE |
| 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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| 510(k) | Device | Decision |
|---|---|---|
| K132679 | Af Viral/Bacterial Filter, BF Viral/Bacterial FilterCAH · Traditional | 04/18/2014SE |
| K133957 | Disposable Adjustable Peep Valve MR Conditional UseBYE · Traditional | 04/14/2014SE |
| K082092 | Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep…BTM · Traditional | 10/15/2008SE |
| K072755 | Galemed CPAP MaskBZD · Traditional | 11/16/2007SE |
| K022124 | Galemed Peak Flow Meter, Models 3751/3752BZH · Traditional | 04/03/2003SE |
| K021742 | Galemed Neb-Easy NebulizerCAF · Traditional | 10/25/2002SE |
Questions and answers
When was Gio Digital Pressure Guages cleared by the FDA?
Gio Digital Pressure Guages (K122627) received a 510(k) decision of Substantially Equivalent on August 22, 2013, 359 days after the submission was received.
What is the product code of K122627?
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.