FDA 510(k)

CO-OXIMETER SOLUTIONS

K-Number: K863825 · 1986-11-24

Decision Date1986-11-24

Product CodeJKS

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

CO-OXIMETER SOLUTIONS is the device name listed in this FDA 510(k) record. The listed applicant is D.R.G. Scientific Industries. It received FDA 510(k) clearance on 1986-11-24 under 510(k) number K863825. The device is classified under product code JKS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO-OXIMETER SOLUTIONS?

CO-OXIMETER SOLUTIONS is a medical device that received FDA 510(k) clearance on 1986-11-24. The listed applicant is D.R.G. Scientific Industries. The 510(k) number is K863825.

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

CO-OXIMETER SOLUTIONS received FDA 510(k) clearance on 1986-11-24, under 510(k) number K863825.

Who is the listed applicant for CO-OXIMETER SOLUTIONS?

The FDA 510(k) record lists D.R.G. Scientific Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO-OXIMETER SOLUTIONS?

The FDA product code for CO-OXIMETER SOLUTIONS is JKS.

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Other records listing D.R.G. Scientific Industries as applicant

K892329OSMOMETER STANDARD SOLUTIONS K870889ACID FUCHSIN SOLUTIONS K863880BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD.K863824SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT.

Related Devices (Code: JKS)

K951485AVOXIMETER 4000A-Vox Systems, Inc.K862253IL 482 CO-OXIMETERInstrumentation Laboratory CO K853990OSM3 HEMOXIMETERRadiometer America, Inc.K833693TEE ADAPTER 9890-FLUSH WINDING 282Shaban Mfg. Co.K833211BILE SALTS MIXTUREAcumedia Manufacturers, Inc.K832066CONTROL 282Bio-Nustics, 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.