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FDA 510(k)

DISPOSABLE TEMPERATURE PROBE COVER

K-Number: K801366 · 1980-07-28

ApplicantBib, Inc.
Decision Date1980-07-28
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE TEMPERATURE PROBE COVER is the device name listed in this FDA 510(k) record. The listed applicant is Bib, Inc.. It received FDA 510(k) clearance on 1980-07-28 under 510(k) number K801366. 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 PROBE COVER?

DISPOSABLE TEMPERATURE PROBE COVER is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is Bib, Inc.. The 510(k) number is K801366.

When did DISPOSABLE TEMPERATURE PROBE COVER receive FDA 510(k) clearance?

DISPOSABLE TEMPERATURE PROBE COVER received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801366.

Who is the listed applicant for DISPOSABLE TEMPERATURE PROBE COVER?

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

What is the FDA product code for DISPOSABLE TEMPERATURE PROBE COVER?

The FDA product code for DISPOSABLE TEMPERATURE PROBE COVER 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 Bib, 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.

K830916VITA/TRAC 4 FUNCTION VITAL SIGN MONITORK801389BARO/TRAC II & VITA/TRAC, VITAL SIGN MONK800596VITA/TRAC 4-FUNCTION VITAL SIGN MONITORK800782PACE-PULSE/COMPUTRAC

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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