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FDA 510(k)

CATHETER, THERMAL DILUTION FIBEROPTIC

K-Number: K781134 · 1978-08-17

ApplicantOximetrix, Inc.
Decision Date1978-08-17
Product CodeDQE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHETER, THERMAL DILUTION FIBEROPTIC is the device name listed in this FDA 510(k) record. The listed applicant is Oximetrix, Inc.. It received FDA 510(k) clearance on 1978-08-17 under 510(k) number K781134. The device is classified under product code DQE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER, THERMAL DILUTION FIBEROPTIC?

CATHETER, THERMAL DILUTION FIBEROPTIC is a medical device that received FDA 510(k) clearance on 1978-08-17. The listed applicant is Oximetrix, Inc.. The 510(k) number is K781134.

When did CATHETER, THERMAL DILUTION FIBEROPTIC receive FDA 510(k) clearance?

CATHETER, THERMAL DILUTION FIBEROPTIC received FDA 510(k) clearance on 1978-08-17, under 510(k) number K781134.

Who is the listed applicant for CATHETER, THERMAL DILUTION FIBEROPTIC?

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

What is the FDA product code for CATHETER, THERMAL DILUTION FIBEROPTIC?

The FDA product code for CATHETER, THERMAL DILUTION FIBEROPTIC is DQE.

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Other records listing Oximetrix, 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.

K853018MODEL 3000 OPTICATH COMPUTERK842622HEMO STATIC/ESU SCALPEL SYSTEMK833966PUMP INFUSION WEARABLE INFUSION PUMPK823007OPTICATH HEPARIN COATED, FLOW-DIRECTK821057FLOW DIRECTED THERMAL-DILUTION INFUSIONK821056FLOW DIRECTED THERMAL-DILUTION CATHETER

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Related Devices (Code: DQE)

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.

K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)Edwards Lifescience, LLCK160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLCK110167PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)Edwards Lifesciences, LLCK091268HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERSHospira, Inc.K062999OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARINHospira, Inc.K061585OPTICATH CENTRAL VENOUS OXIMETRY CATHETERHospira, 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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