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FDA 510(k)

TEMP TRACE

K-Number: K830530 · 1983-04-06

ApplicantProgress Mankind Technology
Decision Date1983-04-06
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TEMP TRACE is the device name listed in this FDA 510(k) record. The listed applicant is Progress Mankind Technology. It received FDA 510(k) clearance on 1983-04-06 under 510(k) number K830530. 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 TEMP TRACE?

TEMP TRACE is a medical device that received FDA 510(k) clearance on 1983-04-06. The listed applicant is Progress Mankind Technology. The 510(k) number is K830530.

When did TEMP TRACE receive FDA 510(k) clearance?

TEMP TRACE received FDA 510(k) clearance on 1983-04-06, under 510(k) number K830530.

Who is the listed applicant for TEMP TRACE?

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

What is the FDA product code for TEMP TRACE?

The FDA product code for TEMP TRACE is FLL.

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Other records listing Progress Mankind Technology as applicant

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K883314PMT 3721-1 EPIDURAL KITK881616PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1K871663PMT TRACTION TONGSK854157PMT ACCUPRESSURE INFUSION SYSTEM 3601K845035ELECTRODE FOR NEUROLOGICAL SURGERY 2111K845036TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600

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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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