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FDA 510(k)

COBE HF80, CAT. #18-580

K-Number: K801178 · 1980-07-28

ApplicantCobe Laboratories, Inc.
Decision Date1980-07-28
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COBE HF80, CAT. #18-580 is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1980-07-28 under 510(k) number K801178. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE HF80, CAT. #18-580?

COBE HF80, CAT. #18-580 is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K801178.

When did COBE HF80, CAT. #18-580 receive FDA 510(k) clearance?

COBE HF80, CAT. #18-580 received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801178.

Who is the listed applicant for COBE HF80, CAT. #18-580?

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

What is the FDA product code for COBE HF80, CAT. #18-580?

The FDA product code for COBE HF80, CAT. #18-580 is FJI.

Other records listing Cobe Laboratories, Inc. as applicant

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Related Devices (Code: FJI)

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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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