Monaghan's Pressure Alarm
FDA 510(k) K821649 · Monaghan Medical Corp.
510(k) numberK821649
Submission
- Device name
- Monaghan's Pressure Alarm
- Applicant
- Monaghan Medical Corp.
Mchenry, IL, US - Received
- June 4, 1982
- Decision date
- August 5, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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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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| K023097 | Truezone Peak Flow MeterBZH · Abbreviated | 03/07/2003SE |
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| K991212 | Modification to Truzone Peak Flow MeterBZH · Abbreviated | 07/01/1999SE |
| K964130 | Aerogear Asthma Action KitBZH · Traditional | 01/10/1997SE |
| K963089 | Truzone Peak Flow MeterBZH · Traditional | 11/06/1996SE |
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Questions and answers
When was Monaghan's Pressure Alarm cleared by the FDA?
Monaghan's Pressure Alarm (K821649) received a 510(k) decision of Substantially Equivalent on August 5, 1982, 62 days after the submission was received.
What is the product code of K821649?
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.