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FDA 510(k)

CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR

K-Number: K864619 · 1987-02-03

ApplicantShiley, Inc.
Decision Date1987-02-03
Product CodeKRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1987-02-03 under 510(k) number K864619. The device is classified under product code KRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR?

CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR is a medical device that received FDA 510(k) clearance on 1987-02-03. The listed applicant is Shiley, Inc.. The 510(k) number is K864619.

When did CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR receive FDA 510(k) clearance?

CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR received FDA 510(k) clearance on 1987-02-03, under 510(k) number K864619.

Who is the listed applicant for CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR?

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 CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR?

The FDA product code for CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR is KRL.

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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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Related Devices (Code: KRL)

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.

K103469STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05Sorin Group Deutschland GmbHK090698CAPIOX BUBBLE TRAP WITH X-COATINGTerumo Cardiovascular SystemsK071231EDAC QUANTIFIERLuna Innovations, Inc.K961364AUTOMATIC TUBING CLAMP SYSTEM (ATC)Rocky Mountain Research, Inc.K961598ELS AUTOMATIC TUBING CLAMP SYSTEMRocky Mountain Research, Inc.K940651SARNS ULTRASONIC AIR SENSOR3M Health Care, Sarns

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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