Ventlab Pressurechek Disosable Column Manometer
FDA 510(k) K120118 · Ventlab Corp.
510(k) numberK120118
Submission
- Device name
- Ventlab Pressurechek Disosable Column Manometer
- Applicant
- Ventlab Corp.
Mocksville, NC, US - Received
- January 17, 2012
- Decision date
- May 24, 2012
- 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
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|---|---|---|---|
| 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 |
| 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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| K173373 | SafeT T-Piece ResuscitatorBTL · Traditional | 11/16/2018SE |
| K102674 | Cuff SentryBSK · Traditional | 07/22/2011SE |
| K093617 | Ventlab 6000 Series HumidifierBTT · Traditional | 01/27/2011SE |
| K093525 | Ace/Statcheck II CO2 Indicator, Ace/Statcheck II CO2 Indicator Arm Assemby Adult…CCK · Special | 12/10/2009SE |
| K090840 | Ventlab 5000 Series Nebulizer Assembly, Cup, Cup W/ Mask, Cup W/ Fitsall Conn.CAF · Traditional | 06/25/2009SE |
| K082204 | Series Sy Disposable Electrosurgical PadODR · Traditional | 08/13/2008SE |
| K063813 | Ventlab Nasal CO2 SAMPLING/O2 Delivery CannulaCCK · Traditional | 03/26/2008SE |
| K040726 | Ventlab Nasal CPAP CannulaBZD · Traditional | 06/03/2004SE |
| K030271 | Ventlab Bacterial Filter, Model BF100CAH · Traditional | 07/07/2003SE |
| K020281 | Modification to Ventlab Hyperinflation Bag SystemNHK · Special | 02/11/2002SE |
Questions and answers
When was Ventlab Pressurechek Disosable Column Manometer cleared by the FDA?
Ventlab Pressurechek Disosable Column Manometer (K120118) received a 510(k) decision of Substantially Equivalent on May 24, 2012, 128 days after the submission was received.
What is the product code of K120118?
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.