Trio Monitor Model 0998-00-0600
FDA 510(k) K032338 · Datascope Corp.
510(k) numberK032338
Submission
- Device name
- Trio Monitor Model 0998-00-0600
- Applicant
- Datascope Corp.
Mahwh, NJ, US - Received
- July 29, 2003
- Decision date
- February 11, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
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| K241958 | WARD-CSS (v1.2.x)MWI · Traditional | Ward 24/7 Aps | 02/14/2025SE |
| K243146 | iCare APPMWI · Traditional | Ihealth Labs, Inc. | 02/03/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | Welch Allyn, Inc. | 12/20/2024SE |
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Questions and answers
When was Trio Monitor Model 0998-00-0600 cleared by the FDA?
Trio Monitor Model 0998-00-0600 (K032338) received a 510(k) decision of Substantially Equivalent on February 11, 2004, 197 days after the submission was received.
What is the product code of K032338?
The FDA product code is MWI – Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.2300.