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FDA 510(k)

IVAC 819 ELECTRONIC THERMOMETER

K-Number: K791209 · 1979-08-03

ApplicantY
Decision Date1979-08-03
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IVAC 819 ELECTRONIC THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Y. It received FDA 510(k) clearance on 1979-08-03 under 510(k) number K791209. 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 IVAC 819 ELECTRONIC THERMOMETER?

IVAC 819 ELECTRONIC THERMOMETER is a medical device that received FDA 510(k) clearance on 1979-08-03. The listed applicant is Y. The 510(k) number is K791209.

When did IVAC 819 ELECTRONIC THERMOMETER receive FDA 510(k) clearance?

IVAC 819 ELECTRONIC THERMOMETER received FDA 510(k) clearance on 1979-08-03, under 510(k) number K791209.

Who is the listed applicant for IVAC 819 ELECTRONIC THERMOMETER?

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

What is the FDA product code for IVAC 819 ELECTRONIC THERMOMETER?

The FDA product code for IVAC 819 ELECTRONIC THERMOMETER is FLL.

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Other records listing Y 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.

K955846MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETERK960280IVAC NEEDLE FREE VALVE ADMINISTRATION SETSK953225IVAC BALL VALCE ADMIN. SETSK934095IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETSK940897IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SETK931550EZ ADMINISTRATION SET

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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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