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FDA 510(k)

SHILEY OXYGENATOR THERMISTOR PROBE

K-Number: K810647 · 1981-04-03

ApplicantShiley, Inc.
Decision Date1981-04-03
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHILEY OXYGENATOR THERMISTOR PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1981-04-03 under 510(k) number K810647. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHILEY OXYGENATOR THERMISTOR PROBE?

SHILEY OXYGENATOR THERMISTOR PROBE is a medical device that received FDA 510(k) clearance on 1981-04-03. The listed applicant is Shiley, Inc.. The 510(k) number is K810647.

When did SHILEY OXYGENATOR THERMISTOR PROBE receive FDA 510(k) clearance?

SHILEY OXYGENATOR THERMISTOR PROBE received FDA 510(k) clearance on 1981-04-03, under 510(k) number K810647.

Who is the listed applicant for SHILEY OXYGENATOR THERMISTOR PROBE?

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

What is the FDA product code for SHILEY OXYGENATOR THERMISTOR PROBE?

The FDA product code for SHILEY OXYGENATOR THERMISTOR PROBE is DWC.

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Other records listing Shiley, 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.

K920594SHILEY PERFUSION TUBING SETSK910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMK911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200K910923BCD ADVANCEDK901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASK903435SHILEY SPECIALIZED TRACHEOSTOMY TUBE

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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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