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FDA 510(k)

FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00

K-Number: K864000 · 1987-01-16

ApplicantFiberoptic Sensor Technlogies, Inc.
Decision Date1987-01-16
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 is the device name listed in this FDA 510(k) record. The listed applicant is Fiberoptic Sensor Technlogies, Inc.. It received FDA 510(k) clearance on 1987-01-16 under 510(k) number K864000. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00?

FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 is a medical device that received FDA 510(k) clearance on 1987-01-16. The listed applicant is Fiberoptic Sensor Technlogies, Inc.. The 510(k) number is K864000.

When did FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 receive FDA 510(k) clearance?

FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 received FDA 510(k) clearance on 1987-01-16, under 510(k) number K864000.

Who is the listed applicant for FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00?

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

What is the FDA product code for FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00?

The FDA product code for FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 is DXO.

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Other records listing Fiberoptic Sensor Technlogies, 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.

K945753FST FIBEROPTIC PRESSURE CONVERTERK950908FST CATH-UD, CATHETERK9454954-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTIONK930171FST DUAL, DUAL PRESSURE URODYNAMICS MONITORK922476URO-PRO 2000K922776FST COUNCIL TIP FOLEY CATHETER

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Related Devices (Code: DXO)

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.

K251367OptoMonitor 3Opsens, Inc.K241418OptoMonitor 3Opsens, Inc.K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLCK202943OptoMonitor 3Opsens, Inc.K193620OptoMonitor 3Opsens, 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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