Ams 3000M
FDA 510(k) K936009 · Acutronic Medical Systems AG
510(k) numberK936009
Submission
- Device name
- Ams 3000M
- Applicant
- Acutronic Medical Systems AG
Jona-Rapper Swril, CH - Received
- December 16, 1993
- Decision date
- May 3, 1995
- 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 |
| K120118 | Ventlab Pressurechek Disosable Column ManometerCAP · Traditional | Ventlab Corp. | 05/24/2012SE |
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| K012691 | Monsoon Critical Care Jet Ventilator and AccessoriesCBK · Traditional | 12/20/2002SE |
| K012693 | Mistral Critical Care Jet Ventilator and AccessoriesCBK · Traditional | 08/01/2002SE |
| K900745 | VS-200S Jet VentilatorCBK · Traditional | 04/29/1991SE |
| K900744 | Ams 3000 Portable Jet VentilatorCBK · Traditional | 04/29/1991SE |
| K883865 | External Jet Synchronizer, Model AMS-1010CBK · Traditional | 06/08/1989SE |
| K863155 | Universal Jet Ventilator Model AMS-1000CBK · Traditional | 09/28/1987SE |
| K863154 | Heated Jet Humidifier Model AMS-1020BTT · Traditional | 01/12/1987SE |
| K862436 | Trans- Circothyrotomy Device (Acc. Ravussin)BTO · Traditional | 11/03/1986SE |
| K862435 | Double Lumen E T AdaptorBZA · Traditional | 10/22/1986SE |
| K862433 | Uni-Jet ConnectorBZA · Traditional | 08/06/1986SE |
Questions and answers
When was Ams 3000M cleared by the FDA?
Ams 3000M (K936009) received a 510(k) decision of Substantially Equivalent on May 3, 1995, 503 days after the submission was received.
What is the product code of K936009?
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.