Ultrasonic Stethoscope
FDA 510(k) K803246 · Sonicaid, Inc.
510(k) numberK803246
Submission
- Device name
- Ultrasonic Stethoscope
- Applicant
- Sonicaid, Inc.
Mchenry, IL, US - Received
- December 23, 1980
- Decision date
- January 28, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K262311 | Alturion Series Diagnostic Ultrasound SystemIYN · Special | Philips Ultrasound, LLC | 08/04/2026SE |
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| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…IYN · Traditional | Samsung Medison Co., Ltd. | 07/28/2026SE |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional | Philips Ultrasound, LLC | 07/27/2026SE |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…IYN · Traditional | Esonic Technology (Wuhan) Co., Ltd. | 07/23/2026SE |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)IYN · Special | Beijing Konted Medical Technology Co.,Ltd | 07/23/2026SE |
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| K833488 | SonicompHEM · Traditional | 11/28/1983SE |
| K833227 | Sonicaid Model D206E Air Emboli-DetectLBA · Traditional | 10/27/1983SE |
Questions and answers
When was Ultrasonic Stethoscope cleared by the FDA?
Ultrasonic Stethoscope (K803246) received a 510(k) decision of Substantially Equivalent on January 28, 1981, 36 days after the submission was received.
What is the product code of K803246?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.