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FDA 510(k)

PROBE COVER

K-Number: K810474 · 1981-03-31

ApplicantNarco Air-Shields
Decision Date1981-03-31
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROBE COVER is the device name listed in this FDA 510(k) record. The listed applicant is Narco Air-Shields. It received FDA 510(k) clearance on 1981-03-31 under 510(k) number K810474. 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 PROBE COVER?

PROBE COVER is a medical device that received FDA 510(k) clearance on 1981-03-31. The listed applicant is Narco Air-Shields. The 510(k) number is K810474.

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

PROBE COVER received FDA 510(k) clearance on 1981-03-31, under 510(k) number K810474.

Who is the listed applicant for PROBE COVER?

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

What is the FDA product code for PROBE COVER?

The FDA product code for PROBE COVER is FLL.

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Other records listing Narco Air-Shields as applicant

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K820114SYSTEM V.HEART RATE/RESPIR. RATE MONIT.K810953MODEL 533 PHOTOTHERAPY UNITK802800NARCO AIR-SHEILDS SYS. 100 MONITOR SYSK802126ISOLETTE INCUBATOR C-100K792592AMBU UNIVERSAL SUCTION PUMPK792499AMBU PAEDI ANAESTHESIA SYSTEM

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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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