Mark III Ultrasonic Scanning System
FDA 510(k) K802917 · Advanced Technology Laboratories, Inc.
510(k) numberK802917
Submission
- Device name
- Mark III Ultrasonic Scanning System
- Applicant
- Advanced Technology Laboratories, Inc.
Mchenry, IL, US - Received
- November 19, 1980
- Decision date
- January 16, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXK – Echocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2330
- Specialty
- Cardiovascular
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| K940423 | Nova Microsonics Access Image Management Network/Access Acquisition ModuleLMD · Traditional | 07/29/1994SE |
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Questions and answers
When was Mark III Ultrasonic Scanning System cleared by the FDA?
Mark III Ultrasonic Scanning System (K802917) received a 510(k) decision of Substantially Equivalent on January 16, 1981, 58 days after the submission was received.
What is the product code of K802917?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.