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FDA 510(k)

VITALSENSE

K-Number: K033534 · 2004-04-22

ApplicantMini-Mitter Co., Inc.
Decision Date2004-04-22
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VITALSENSE is the device name listed in this FDA 510(k) record. The listed applicant is Mini-Mitter Co., Inc.. It received FDA 510(k) clearance on 2004-04-22 under 510(k) number K033534. 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 VITALSENSE?

VITALSENSE is a medical device that received FDA 510(k) clearance on 2004-04-22. The listed applicant is Mini-Mitter Co., Inc.. The 510(k) number is K033534.

When did VITALSENSE receive FDA 510(k) clearance?

VITALSENSE received FDA 510(k) clearance on 2004-04-22, under 510(k) number K033534.

Who is the listed applicant for VITALSENSE?

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

What is the FDA product code for VITALSENSE?

The FDA product code for VITALSENSE is FLL.

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Other records listing Mini-Mitter Co., 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.

K011430ACTIWARE-PLMSK991045MINI-LOGGER SERIES 2000K991033ACTIWATCH-SCOREK983533ACTIWATCH

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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