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FDA 510(k)

NEW COBE SATURATION/HEMATOCRIT MONITOR

K-Number: K904336 · 1990-12-27

ApplicantCobe Laboratories, Inc.
Decision Date1990-12-27
Product CodeGKF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

NEW COBE SATURATION/HEMATOCRIT MONITOR 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 1990-12-27 under 510(k) number K904336. The device is classified under product code GKF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEW COBE SATURATION/HEMATOCRIT MONITOR?

NEW COBE SATURATION/HEMATOCRIT MONITOR is a medical device that received FDA 510(k) clearance on 1990-12-27. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K904336.

When did NEW COBE SATURATION/HEMATOCRIT MONITOR receive FDA 510(k) clearance?

NEW COBE SATURATION/HEMATOCRIT MONITOR received FDA 510(k) clearance on 1990-12-27, under 510(k) number K904336.

Who is the listed applicant for NEW COBE SATURATION/HEMATOCRIT MONITOR?

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 NEW COBE SATURATION/HEMATOCRIT MONITOR?

The FDA product code for NEW COBE SATURATION/HEMATOCRIT MONITOR is GKF.

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Other records listing Cobe Laboratories, Inc. 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.

K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK902437COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTERK902631COBE ICU CONVERSION KIT

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Related Devices (Code: GKF)

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.

K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)Instrumentation Laboratory COK983551CRIT-SCAN II MONITORIn-Line Diagnostics Corp.K981425STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERSNova Biomedical Corp.K981426STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERSNova Biomedical Corp.K981427STAT PROFILE M ANALYZERNova Biomedical Corp.K953519MICROSPIN 24Vulcon Technologies

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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