Sierra Battery Sealed Lead Acid Battery System
FDA 510(k) K955095 · Sierra Battery, Inc.
510(k) numberK955095
Submission
- Device name
- Sierra Battery Sealed Lead Acid Battery System
- Applicant
- Sierra Battery, Inc.
Reno, NV, US - Received
- November 7, 1995
- Decision date
- December 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Sierra Battery Sealed Lead Acid Battery System cleared by the FDA?
Sierra Battery Sealed Lead Acid Battery System (K955095) received a 510(k) decision of Substantially Equivalent on December 21, 1995, 44 days after the submission was received.
What is the product code of K955095?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.