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FDA 510(k)

MEDSAT OXYGEN SATURATION SYSTEM

K-Number: K941922 · 1995-02-17

ApplicantMedtronic Bio-Medicus, Inc.
Decision Date1995-02-17
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDSAT OXYGEN SATURATION 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 1995-02-17 under 510(k) number K941922. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDSAT OXYGEN SATURATION SYSTEM?

MEDSAT OXYGEN SATURATION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-02-17. The listed applicant is Medtronic Bio-Medicus, Inc.. The 510(k) number is K941922.

When did MEDSAT OXYGEN SATURATION SYSTEM receive FDA 510(k) clearance?

MEDSAT OXYGEN SATURATION SYSTEM received FDA 510(k) clearance on 1995-02-17, under 510(k) number K941922.

Who is the listed applicant for MEDSAT OXYGEN SATURATION 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 MEDSAT OXYGEN SATURATION SYSTEM?

The FDA product code for MEDSAT OXYGEN SATURATION SYSTEM is DRY.

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Other records listing Medtronic Bio-Medicus, Inc. as applicant

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K973237CSS-CARDIOPLEGIA SAFETY SYSTEMK973011BPX80 BIO-PUMP (BPX80)K954501BIOTREND OXYGEN SATURATION & HEMATOCRIT 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: DRY)

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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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