Pb-A Lead-Acid Battery Conversion Kit
FDA 510(k) K875106 · Diagnostic Imaging Specialists Corp.
510(k) numberK875106
Submission
- Device name
- Pb-A Lead-Acid Battery Conversion Kit
- Applicant
- Diagnostic Imaging Specialists Corp.
St. Malo, Manitoba, CA - Received
- December 14, 1987
- Decision date
- February 22, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Pb-A Lead-Acid Battery Conversion Kit cleared by the FDA?
Pb-A Lead-Acid Battery Conversion Kit (K875106) received a 510(k) decision of Substantially Equivalent on February 22, 1988, 70 days after the submission was received.
What is the product code of K875106?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.