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FDA 510(k)

TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS

K-Number: K830197 · 1983-11-29

ApplicantDiamond Shamrock Corp.
Decision Date1983-11-29
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Shamrock Corp.. It received FDA 510(k) clearance on 1983-11-29 under 510(k) number K830197. The device is classified under product code KLK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS?

TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS is a medical device that received FDA 510(k) clearance on 1983-11-29. The listed applicant is Diamond Shamrock Corp.. The 510(k) number is K830197.

When did TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS receive FDA 510(k) clearance?

TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS received FDA 510(k) clearance on 1983-11-29, under 510(k) number K830197.

Who is the listed applicant for TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS?

The FDA 510(k) record lists Diamond Shamrock Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS?

The FDA product code for TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS is KLK.

Related Clinical Trials

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.

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Other records listing Diamond Shamrock Corp. 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.

K760262RADIOASSY KIT, 3H-FOLATE

Related Devices (Code: KLK)

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.

K003943MICROGAS 7650 TRANSCUTANEOUS MONITORLinde Medical Sensors AGK991644MICROGAS 7650 TRANSCUTANEOUS MONITORLinde Medical Sensors AGK980287SIEMENS SC9000/SC9015 TCP02/C02 MODULESiemens Medical Solutions USA, Inc.K924709SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETEAir-Shields, Inc.K924679OXYCARE(TM) OXYGEN CONTROLLER/MONITORAir-Shields Vickers, Inc.K925910HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULEHewlett-Packard Co.

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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