Nova Microsonics Capricorn Digital Image Systems
FDA 510(k) K905248 · Advanced Technology Laboratories, Inc.
510(k) numberK905248
Submission
- Device name
- Nova Microsonics Capricorn Digital Image Systems
- Applicant
- Advanced Technology Laboratories, Inc.
Bothell, WA, US - Received
- November 21, 1990
- Decision date
- February 28, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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Questions and answers
When was Nova Microsonics Capricorn Digital Image Systems cleared by the FDA?
Nova Microsonics Capricorn Digital Image Systems (K905248) received a 510(k) decision of Substantially Equivalent on February 28, 1991, 99 days after the submission was received.
What is the product code of K905248?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.