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FDA 510(k)

BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM

K-Number: K954501 · 1996-01-16

ApplicantMedtronic Bio-Medicus, Inc.
Decision Date1996-01-16
Product CodeDTY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Bio-Medicus, Inc.. It received FDA 510(k) clearance on 1996-01-16 under 510(k) number K954501. 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 & HEMATOCRIT SYSTEM?

BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-16. The listed applicant is Medtronic Bio-Medicus, Inc.. The 510(k) number is K954501.

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

BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM received FDA 510(k) clearance on 1996-01-16, under 510(k) number K954501.

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

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

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

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

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Other records listing Medtronic Bio-Medicus, 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.

K973237CSS-CARDIOPLEGIA SAFETY SYSTEMK973011BPX80 BIO-PUMP (BPX80)K941922MEDSAT OXYGEN SATURATION SYSTEMK936091MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLERK941921BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550K924208BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)

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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.

K093650BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEMMedtronic, Inc.K963698CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4International Biophysics Corp.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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