FDA 510(k)

CEB

K-Number: K834068 · 1984-01-03

Decision Date1984-01-03

Product CodeJSJ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

CEB is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1984-01-03 under 510(k) number K834068. The device is classified under product code JSJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEB?

CEB is a medical device that received FDA 510(k) clearance on 1984-01-03. The listed applicant is Remel Co.. The 510(k) number is K834068.

When did CEB receive FDA 510(k) clearance?

CEB received FDA 510(k) clearance on 1984-01-03, under 510(k) number K834068.

Who is the listed applicant for CEB?

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

What is the FDA product code for CEB?

The FDA product code for CEB is JSJ.

Other records listing Remel Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.