Dinamap MPS Select Portable Monitor
FDA 510(k) K982342 · Critikon Company, LLC
510(k) numberK982342
Submission
- Device name
- Dinamap MPS Select Portable Monitor
- Applicant
- Critikon Company, LLC
Tampa, FL, US - Received
- July 6, 1998
- Decision date
- August 14, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K242750 | Central StationMSX · Traditional | Nihon Kohden Digital Health Solutions, LLC | 06/05/2025SE |
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More from Draeger Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002248 | Dinamap Pro 1000 Monitor, Model 1000DXN · Traditional | 09/21/2000SE |
| K000500 | Dinamap Advanced Nibp ModuleDXN · Traditional | 05/26/2000SE |
| K992638 | Dinamap Pro Series Monitor, Models 100, 200, 300, 400MWI · Traditional | 02/24/2000SE |
| K943709 | Dinamap Plus Vital Signs MonoitorDPS · Traditional | 06/16/1995SE |
| K942700 | Dinamap Vital Signs Monitor Models 9300 and 9320/9340MHX · Traditional | 03/01/1995SE |
| K933404 | Critikon Central Statin MonitorDPS · Traditional | 02/09/1994SE |
| K933050 | Changes to Protectiv(Tm) & Jelco(Tm) Winged CathFOZ · Traditional | 12/14/1993SE |
| K915697 | Critikon Vital Signs ModuleDXN · Traditional | 07/01/1993SE |
| K921295 | Intravenous Catheters ModificationsFGO · Traditional | 05/17/1993SE |
| K912188 | Dinamap Plus Physiological Monitor Model 8700MHX · Traditional | 12/04/1991SE |
Questions and answers
When was Dinamap MPS Select Portable Monitor cleared by the FDA?
Dinamap MPS Select Portable Monitor (K982342) received a 510(k) decision of Substantially Equivalent on August 14, 1998, 39 days after the submission was received.
What is the product code of K982342?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.