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FDA 510(k)

BASIS DIGITAL THERMOMETER

K-Number: K952159 · 1995-09-22

ApplicantPolymedica Industries, Inc.
Decision Date1995-09-22
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BASIS DIGITAL THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Polymedica Industries, Inc.. It received FDA 510(k) clearance on 1995-09-22 under 510(k) number K952159. 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 BASIS DIGITAL THERMOMETER?

BASIS DIGITAL THERMOMETER is a medical device that received FDA 510(k) clearance on 1995-09-22. The listed applicant is Polymedica Industries, Inc.. The 510(k) number is K952159.

When did BASIS DIGITAL THERMOMETER receive FDA 510(k) clearance?

BASIS DIGITAL THERMOMETER received FDA 510(k) clearance on 1995-09-22, under 510(k) number K952159.

Who is the listed applicant for BASIS DIGITAL THERMOMETER?

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

What is the FDA product code for BASIS DIGITAL THERMOMETER?

The FDA product code for BASIS DIGITAL THERMOMETER is FLL.

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Other records listing Polymedica Industries, 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.

K964398SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTEDK971045BASIS FLEXIBLE TIP DIGITAL THERMOMETERK964701MITRAFLEX PIGMENTED WOUND DRESSINGK963623SPYROFLEX PIGMENTED WOUND DRESSINGK962991BASIS BABY-TEMP PACIFIER DIGITAL THEROMETERK955383SPYROCOLLOID WOUND DRESSING

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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

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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