NS Series Vacuum/Pressure Gauges, Cuff Pressure Monitors
FDA 510(k) K081778 · Instrumentation Industries, Inc.
510(k) numberK081778
Submission
- Device name
- NS Series Vacuum/Pressure Gauges, Cuff Pressure Monitors
- Applicant
- Instrumentation Industries, Inc.
Bethel Park, PA, US - Received
- June 23, 2008
- Decision date
- September 12, 2008
- 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 |
| 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 |
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|---|---|---|
| K180510 | NS 120P-TRS Airway Pressure GaugeCAP · Traditional | 05/01/2019SE |
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| K113644 | Pilot Tube Repair KitBSK · Special | 01/26/2012SE |
| K102127 | Endotracheal Tube ChangersLNZ · Special | 08/27/2010SE |
| K101857 | RTC-24 VP Metered Dose Inhaler Adapter, Model RTC 24-VCAF · Special | 07/22/2010SE |
| K091111 | RTC Metered Dose Inhaler Adapters-Single Patient Use, Model RTC 24-V, RTC Mdi Adapter…CAF · Traditional | 12/02/2009SE |
| K081693 | NS Series Nif (Negative Inspiratory Force) MetersBXR · Traditional | 09/11/2008SE |
| K991355 | Metered Dose Inhaler Adapter-Disposable, Adapter ReusableCAF · Traditional | 01/27/2000SE |
| K992670 | Oxygen Enrichment Kit, Models SG 066, SG 067CBK · Traditional | 09/17/1999ST |
| K991785 | Manual Jet Ventilator (with Regulator and Gauge), Manual Jet Ventilator (Without…BTL · Traditional | 08/17/1999SE |
Questions and answers
When was NS Series Vacuum/Pressure Gauges, Cuff Pressure Monitors cleared by the FDA?
NS Series Vacuum/Pressure Gauges, Cuff Pressure Monitors (K081778) received a 510(k) decision of Substantially Equivalent on September 12, 2008, 81 days after the submission was received.
What is the product code of K081778?
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.