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FDA 510(k)

HEMO FEC

K-Number: K780214 · 1978-05-03

ApplicantBoehringer Mannheim Corp.
Decision Date1978-05-03
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMO FEC is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1978-05-03 under 510(k) number K780214. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMO FEC?

HEMO FEC is a medical device that received FDA 510(k) clearance on 1978-05-03. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K780214.

When did HEMO FEC receive FDA 510(k) clearance?

HEMO FEC received FDA 510(k) clearance on 1978-05-03, under 510(k) number K780214.

Who is the listed applicant for HEMO FEC?

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

What is the FDA product code for HEMO FEC?

The FDA product code for HEMO FEC is KHE.

Other records listing Boehringer Mannheim Corp. as applicant

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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.

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