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FDA 510(k)

ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE

K-Number: K912742 · 1992-04-20

ApplicantSpacelabs, Inc.
Decision Date1992-04-20
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1992-04-20 under 510(k) number K912742. 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 ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE?

ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 1992-04-20. The listed applicant is Spacelabs, Inc.. The 510(k) number is K912742.

When did ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE receive FDA 510(k) clearance?

ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE received FDA 510(k) clearance on 1992-04-20, under 510(k) number K912742.

Who is the listed applicant for ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE?

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

What is the FDA product code for ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE?

The FDA product code for ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE is FLL.

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Other records listing Spacelabs, 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.

K954962SPACELABS MEDICAL MULTIGAS ANALYZERK951605SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEMK950779HEART RATE VARIABILITY SOFTWARE OPTIONK941165COMET CAPNOGRAPH MODULEK923788SPACE LABS MODEL 90560K913038SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION

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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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