Ambu Disposable Pressure Manometer
FDA 510(k) K040991 · Ambu, Inc.
510(k) numberK040991
Submission
- Device name
- Ambu Disposable Pressure Manometer
- Applicant
- Ambu, Inc.
Linthicum, MD, US - Received
- April 16, 2004
- Decision date
- July 22, 2004
- 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
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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| K051529 | Ambu Neuroline GroundGXY · Traditional | 08/04/2005SE |
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| K042843 | Ambu Spur II Infant and Pediatric Single Patient Use ResuscitatorsBTM · Traditional | 11/12/2004SE |
| K041734 | Ambu Disposable ECG ElectrodeDRX · Traditional | 09/22/2004SE |
| K041026 | Ambu Blue Sensor, MRX, ECG Electrode Product #:MRX-00-SDRX · Traditional | 06/28/2004SE |
| K032278 | Ambu Neuroline Single Patient Eeg/Ep Cup ElectrodeGXY · Traditional | 03/05/2004SE |
| K032421 | Ambu Pediatric Multi-Function Defibrillation ElectrodeMKJ · Traditional | 02/27/2004SE |
| K010583 | Ambu Gel, Hydrogel Burn DressingMGQ · Traditional | 05/25/2001SE |
| K993278 | Ambu Neonate Silicone ResuscitatorBTM · Traditional | 05/17/2000SE |
| K992902 | Ambu Hand Power Suction PumpBSY · Traditional | 10/25/1999SE |
Questions and answers
When was Ambu Disposable Pressure Manometer cleared by the FDA?
Ambu Disposable Pressure Manometer (K040991) received a 510(k) decision of Substantially Equivalent on July 22, 2004, 97 days after the submission was received.
What is the product code of K040991?
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.