The AccurSound Electronic Stethoscope AS-101 (“AS-101”) is a device designed for healthcare professionals used in clinical settings. The AS-101 can detect and amplify the sounds of the…
The AccurSound Electronic Stethoscope AS-101 (“AS-101”) is a device designed for healthcare professionals used in clinical settings. The AS-101 can detect and amplify the sounds of the heart, lungs, arteries, veins, and other internal organs. The microphone-equipped disposable sensor detects and amplifies the sounds from the patient’s body. The auscultation sound is digitally processed and filtered, electronically amplified in the hub unit. The anti-noise function reduces ambient noise and echoes, then transferred to the earpiece. The multi-channel design allows healthcare professionals to attach disposable sensors onto patient’s body, by switching modes from handheld single-channel recording to four-channel stationery and continuously auscultation based on different requirements of clinical applications or physical assessments.
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Heroic Faith | Listed by | Heroic Faith International Ltd., Taiwan |
| FDA product code | DQD |
| Device type | Stethoscope, Electronic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1875 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2023-09-18 |
| Record revised | 2024-11-25 (version 3) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.