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FDA 510(k)

BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM

K-Number: K093650 · 2010-02-17

ApplicantMedtronic, Inc.
Decision Date2010-02-17
Product CodeDTY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2010-02-17 under 510(k) number K093650. The device is classified under product code DTY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM?

BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM is a medical device that received FDA 510(k) clearance on 2010-02-17. The listed applicant is Medtronic, Inc.. The 510(k) number is K093650.

When did BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM receive FDA 510(k) clearance?

BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM received FDA 510(k) clearance on 2010-02-17, under 510(k) number K093650.

Who is the listed applicant for BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM?

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

What is the FDA product code for BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM?

The FDA product code for BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM is DTY.

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Related Devices (Code: DTY)

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.

K963698CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4International Biophysics Corp.K954501BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEMMedtronic Bio-Medicus, Inc.K902654CDI (TM) SYSTEM 100 MONITORING SYSTEM3M Health Care, Ltd.K900860PERFUSION MONITORCardio Metrics, Inc.K864703MODIFIED GAS-STAT(TM) MONITORING SYSTEMCardiovascular Devices, Inc.K840749GAST STAT MONITORING SYSTEMCardiovascular Devices, Inc.

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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