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FDA 510(k)

CO-SET

K-Number: K833997 · 1984-04-17

ApplicantAmerican Edwards Laboratories
Decision Date1984-04-17
Product Code
DecisionSubstantially Equivalent

Device Summary

CO-SET is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1984-04-17 under 510(k) number K833997. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO-SET?

CO-SET is a medical device that received FDA 510(k) clearance on 1984-04-17. The listed applicant is American Edwards Laboratories. The 510(k) number is K833997.

When did CO-SET receive FDA 510(k) clearance?

CO-SET received FDA 510(k) clearance on 1984-04-17, under 510(k) number K833997.

Who is the listed applicant for CO-SET?

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

Other records listing American Edwards Laboratories 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.

K873485EDSLAB (R) OCCLUSION BALLOON CATHETERK872596TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2K870444HOMEPRO II VOLUMETRIC INFUSION PUMPK864997MEDTRAC VP VOLUMETRIC INFUSION PUMPK864330SHEAR FORCE GAUGE

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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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