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FDA 510(k)

B-D ASSURE EAR THERMOMETER

K-Number: K971994 · 1998-05-01

ApplicantBecton Dickinson Consumer Products
Decision Date1998-05-01
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

B-D ASSURE EAR THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Consumer Products. It received FDA 510(k) clearance on 1998-05-01 under 510(k) number K971994. 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 B-D ASSURE EAR THERMOMETER?

B-D ASSURE EAR THERMOMETER is a medical device that received FDA 510(k) clearance on 1998-05-01. The listed applicant is Becton Dickinson Consumer Products. The 510(k) number is K971994.

When did B-D ASSURE EAR THERMOMETER receive FDA 510(k) clearance?

B-D ASSURE EAR THERMOMETER received FDA 510(k) clearance on 1998-05-01, under 510(k) number K971994.

Who is the listed applicant for B-D ASSURE EAR THERMOMETER?

The FDA 510(k) record lists Becton Dickinson Consumer Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B-D ASSURE EAR THERMOMETER?

The FDA product code for B-D ASSURE EAR THERMOMETER is FLL.

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Other records listing Becton Dickinson Consumer Products 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.

K943683B-D SAFE-CLIPK941379ACE SPORTS TAPE

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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