FDA 510(k)

EBSS-EARLE'S BALANCE SALT SOLUTION

K-Number: K850523 · 1985-02-27

Decision Date1985-02-27

Product CodeKIT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

EBSS-EARLE'S BALANCE SALT SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Mediatech, Inc.. It received FDA 510(k) clearance on 1985-02-27 under 510(k) number K850523. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBSS-EARLE'S BALANCE SALT SOLUTION?

EBSS-EARLE'S BALANCE SALT SOLUTION is a medical device that received FDA 510(k) clearance on 1985-02-27. The listed applicant is Mediatech, Inc.. The 510(k) number is K850523.

When did EBSS-EARLE'S BALANCE SALT SOLUTION receive FDA 510(k) clearance?

EBSS-EARLE'S BALANCE SALT SOLUTION received FDA 510(k) clearance on 1985-02-27, under 510(k) number K850523.

Who is the listed applicant for EBSS-EARLE'S BALANCE SALT SOLUTION?

The FDA 510(k) record lists Mediatech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EBSS-EARLE'S BALANCE SALT SOLUTION?

The FDA product code for EBSS-EARLE'S BALANCE SALT SOLUTION is KIT.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.