Ab Mando
US Last updated 23 May 2026
- Devices
- 1
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Mandometer Iii Ref DEN070014
FDA establishments
- Ab Mando HUDDINGE Stockholm · SE FEI 3009128345
What Ab Mando makes
Ab Mando manufactures the Mandometer III, a device designed for measuring blood pressure in clinical settings, likely used for monitoring or diagnostic purposes.
The Mandometer III is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Ab Mando manufacture?
Ab Mando specializes in the Mandometer III, a device intended for measuring blood pressure in clinical environments. This device is likely used for diagnostic or monitoring purposes in healthcare settings.
Where is Ab Mando based?
Ab Mando is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution within the region.
How are Ab Mando’s devices classified under FDA regulations?
The Mandometer III is classified as a Class II medical device by the FDA. This classification indicates moderate risk, requiring specific controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
Which regulatory registries or databases list Ab Mando’s devices?
The Mandometer III is listed via the FDA’s 510(k) pathway, meaning it has undergone premarket notification review to demonstrate substantial equivalence to a legally marketed predicate device. This registration is publicly available in the FDA’s 510(k) database.
Information
- Country
- US