FDA 510(k)

C-STAT/1000

K-Number: K880876 · 1988-05-20

Decision Date1988-05-20

Product CodeLHC

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

C-STAT/1000 is the device name listed in this FDA 510(k) record. The listed applicant is Sonne Medical, Inc.. It received FDA 510(k) clearance on 1988-05-20 under 510(k) number K880876. The device is classified under product code LHC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-STAT/1000?

C-STAT/1000 is a medical device that received FDA 510(k) clearance on 1988-05-20. The listed applicant is Sonne Medical, Inc.. The 510(k) number is K880876.

When did C-STAT/1000 receive FDA 510(k) clearance?

C-STAT/1000 received FDA 510(k) clearance on 1988-05-20, under 510(k) number K880876.

Who is the listed applicant for C-STAT/1000?

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

What is the FDA product code for C-STAT/1000?

The FDA product code for C-STAT/1000 is LHC.

Related Devices (Code: LHC)

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.

K153713Getinge Series Warming CabinetGetinge Sourcing, LLC K152522ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesEcolab, Inc.K083417INTRATEMP SOLUTION WARMERC Change Surgical, LLC K080609SWC/DWC WARMING CABINETSMac Medical K051819C CHANGE SOLUTION WARMERC Change Surgical, LLC K0232831075LD HUSH-SLUSHO.R. Solutions, Inc.

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.