Aspect Acquisition Module (Aam)
FDA 510(k) K954875 · Aspect Electronics, Inc.
510(k) numberK954875
Submission
- Device name
- Aspect Acquisition Module (Aam)
- Applicant
- Aspect Electronics, Inc.
San Leandro, CA, US - Received
- October 24, 1995
- Decision date
- January 2, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K032022 | Digital ImagerLMA · Traditional | Pyramid Medical, Inc. | 09/02/2003SE |
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Questions and answers
When was Aspect Acquisition Module (Aam) cleared by the FDA?
Aspect Acquisition Module (Aam) (K954875) received a 510(k) decision of Substantially Equivalent on January 2, 1996, 70 days after the submission was received.
What is the product code of K954875?
The FDA product code is LMA – Digitizer, Image, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2030.