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FDA 510(k)

DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES

K-Number: K111282 · 2011-08-11

ApplicantStarboard Medical, LLC
Decision Date2011-08-11
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES is the device name listed in this FDA 510(k) record. The listed applicant is Starboard Medical, LLC. It received FDA 510(k) clearance on 2011-08-11 under 510(k) number K111282. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES?

DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES is a medical device that received FDA 510(k) clearance on 2011-08-11. The listed applicant is Starboard Medical, LLC. The 510(k) number is K111282.

When did DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES receive FDA 510(k) clearance?

DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES received FDA 510(k) clearance on 2011-08-11, under 510(k) number K111282.

Who is the listed applicant for DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES?

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

What is the FDA product code for DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES?

The FDA product code for DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES is FLL.

Related Clinical Trials

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.

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Other records listing Starboard Medical, LLC 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.

K111050ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR

Related Devices (Code: FLL)

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.

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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