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FDA 510(k)

DISPOSABLE THERMOMETER PROBE SHEATHS

K-Number: K152690 · 2016-01-15

ApplicantPinghu Sama Medical Packing Co., Ltd.
Decision Date2016-01-15
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE THERMOMETER PROBE SHEATHS is the device name listed in this FDA 510(k) record. The listed applicant is Pinghu Sama Medical Packing Co., Ltd.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K152690. 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 THERMOMETER PROBE SHEATHS?

DISPOSABLE THERMOMETER PROBE SHEATHS is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Pinghu Sama Medical Packing Co., Ltd.. The 510(k) number is K152690.

When did DISPOSABLE THERMOMETER PROBE SHEATHS receive FDA 510(k) clearance?

DISPOSABLE THERMOMETER PROBE SHEATHS received FDA 510(k) clearance on 2016-01-15, under 510(k) number K152690.

Who is the listed applicant for DISPOSABLE THERMOMETER PROBE SHEATHS?

The FDA 510(k) record lists Pinghu Sama Medical Packing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE THERMOMETER PROBE SHEATHS?

The FDA product code for DISPOSABLE THERMOMETER PROBE SHEATHS is FLL.

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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