NeoBeat, NeoBeat Mini
FDA 510(k) K232111 · Laerdal Medical AS
510(k) numberK232111
Submission
- Device name
- NeoBeat, NeoBeat Mini
- Applicant
- Laerdal Medical AS
Stavanger, NO - Received
- July 14, 2023
- Decision date
- June 25, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K253436 | c-med0 alphaMWI · Traditional | Cosinuss GmbH | 04/30/2026SE |
| K250135 | WAVE Clinical Platform (2.0.000)MWI · Traditional | Baxter Healthcare Corp/ Excel Medical | 01/16/2026SE |
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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 |
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Questions and answers
When was NeoBeat, NeoBeat Mini cleared by the FDA?
NeoBeat, NeoBeat Mini (K232111) received a 510(k) decision of Substantially Equivalent on June 25, 2024, 347 days after the submission was received.
What is the product code of K232111?
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.