Ausculthing OY
FI Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
AusculThing ACC Ref K230823
What Ausculthing OY makes
Ausculthing OY manufactures the AusculThing ACC, a device designed for auscultation and diagnostic evaluation of heart and lung sounds, likely incorporating digital recording and analysis capabilities for clinical assessment.
The AusculThing ACC is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Ausculthing OY manufacture?
Ausculthing OY specializes in auscultation devices. Specifically, they produce the AusculThing ACC, which is designed for evaluating heart and lung sounds. This device likely includes digital recording and analysis features to assist clinicians in diagnostic assessments.
Where is Ausculthing OY based?
Ausculthing OY is headquartered in the United States. The company’s location is relevant for regulatory compliance, manufacturing oversight, and customer support.
How are Ausculthing OY’s devices classified in the US?
The AusculThing ACC is classified as a Class II medical device under US regulations. This classification indicates moderate risk and requires compliance with specific controls, including design validation and manufacturing quality standards, to ensure safety and performance.
Which regulatory registries or pathways list Ausculthing OY’s devices?
The AusculThing ACC is listed under the FDA’s 510(k) pathway, meaning it has undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device. This pathway is used for devices deemed to have low to moderate risk.
Information
- Country
- FI