Infant C.P.A.P. Monitor
FDA 510(k) K896136 · Hudson Oxygen Therapy Sales Co.
510(k) numberK896136
Submission
- Device name
- Infant C.P.A.P. Monitor
- Applicant
- Hudson Oxygen Therapy Sales Co.
Temecula, CA, US - Received
- October 23, 1989
- Decision date
- January 9, 1990
- 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
| 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 |
More from Ventlab Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K902062 | Peep ValveBYE · Traditional | 09/04/1990SE |
| K900783 | Mdi AdaptorCAF · Traditional | 07/18/1990SE |
| K900470 | In-The NebulizerCAF · Traditional | 05/18/1990SE |
| K895589 | Manual ResuscitatorBTM · Traditional | 03/30/1990SE |
| K895747 | Ventilarm II Portable Airway Pressure MonitorCAP · Traditional | 10/27/1989SE |
| K895231 | Catalog No. 1755 1S0-NEB, a Filtered NebulizerCAF · Traditional | 10/27/1989SE |
| K890035 | Bacteria FilterCAH · Traditional | 05/05/1989SE |
| K870895 | No. 1552, Valved Venti-CompCBP · Traditional | 05/04/1987SE |
| K871157 | C.P.A.P. Nasal CannulaBZD · Traditional | 04/21/1987SE |
| K870138 | 1160 Simple Isolation Valve & 1161 Filtered ValveCBP · Traditional | 03/06/1987SE |
Questions and answers
When was Infant C.P.A.P. Monitor cleared by the FDA?
Infant C.P.A.P. Monitor (K896136) received a 510(k) decision of Substantially Equivalent on January 9, 1990, 78 days after the submission was received.
What is the product code of K896136?
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.