FDA 510(k)

BARIUM ENEMAS

K-Number: K828661 · 1983-01-17

Decision Date1983-01-17

Product Code

DecisionSubstantially Equivalent

Device Summary

BARIUM ENEMAS is the device name listed in this FDA 510(k) record. The listed applicant is The Healthcare Group, Inc.. It received FDA 510(k) clearance on 1983-01-17 under 510(k) number K828661. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARIUM ENEMAS?

BARIUM ENEMAS is a medical device that received FDA 510(k) clearance on 1983-01-17. The listed applicant is The Healthcare Group, Inc.. The 510(k) number is K828661.

When did BARIUM ENEMAS receive FDA 510(k) clearance?

BARIUM ENEMAS received FDA 510(k) clearance on 1983-01-17, under 510(k) number K828661.

Who is the listed applicant for BARIUM ENEMAS?

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

Related Clinical Trials

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Other records listing The Healthcare Group, Inc. as applicant

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Official Source

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