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FDA 510(k)

COBE SATURATION CELL

K-Number: K843709 · 1984-10-24

ApplicantCobe Laboratories, Inc.
Decision Date1984-10-24
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE SATURATION CELL 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 1984-10-24 under 510(k) number K843709. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE SATURATION CELL?

COBE SATURATION CELL is a medical device that received FDA 510(k) clearance on 1984-10-24. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K843709.

When did COBE SATURATION CELL receive FDA 510(k) clearance?

COBE SATURATION CELL received FDA 510(k) clearance on 1984-10-24, under 510(k) number K843709.

Who is the listed applicant for COBE SATURATION CELL?

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 SATURATION CELL?

The FDA product code for COBE SATURATION CELL is DRY.

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Other records listing Cobe Laboratories, Inc. 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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