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FDA 510(k)

ESOPHAGEAL PROBE W/TEMP. INDICATOR

K-Number: K830353 · 1983-04-06

ApplicantScience Development Corp.
Decision Date1983-04-06
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL PROBE W/TEMP. INDICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Science Development Corp.. It received FDA 510(k) clearance on 1983-04-06 under 510(k) number K830353. 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 ESOPHAGEAL PROBE W/TEMP. INDICATOR?

ESOPHAGEAL PROBE W/TEMP. INDICATOR is a medical device that received FDA 510(k) clearance on 1983-04-06. The listed applicant is Science Development Corp.. The 510(k) number is K830353.

When did ESOPHAGEAL PROBE W/TEMP. INDICATOR receive FDA 510(k) clearance?

ESOPHAGEAL PROBE W/TEMP. INDICATOR received FDA 510(k) clearance on 1983-04-06, under 510(k) number K830353.

Who is the listed applicant for ESOPHAGEAL PROBE W/TEMP. INDICATOR?

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

What is the FDA product code for ESOPHAGEAL PROBE W/TEMP. INDICATOR?

The FDA product code for ESOPHAGEAL PROBE W/TEMP. INDICATOR is FLL.

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Other records listing Science Development Corp. as applicant

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K843617SDC SILICONE SUMP DRAINK842491SDC SILICONE FORCEP SHODS PRODUCTK833355SDC VASCULAR TIESK832090SCD SKIN TEMP. SENSORS #3400 ETCK832392SDC ORAL-RECTAL TEMP. PROBEK832391QT-100 ELECTRONIC TEMP. MONITOR

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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

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