FDA 510(k)

Temp Pal

K-번호: K202603 · 2021-07-22

결정일2021-07-22

제품 코드FLL

자문 위원회HO

결정Substantially Equivalent

기기 요약

Temp Pal is the device name listed in this FDA 510(k) record. The listed applicant is Iweecare Co., Ltd.. It received FDA 510(k) clearance on 2021-07-22 under 510(k) number K202603. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Temp Pal?

Temp Pal is a medical device that received FDA 510(k) clearance on 2021-07-22. The listed applicant is Iweecare Co., Ltd.. The 510(k) number is K202603.

When did Temp Pal receive FDA 510(k) clearance?

Temp Pal received FDA 510(k) clearance on 2021-07-22, under 510(k) number K202603.

Who is the listed applicant for Temp Pal?

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

What is the FDA product code for Temp Pal?

The FDA product code for Temp Pal is FLL.

Iweecare Co., Ltd.를 신청인으로 등재한 기타 기록

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

K222588Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1

관련 기기 (코드: FLL)

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.K250470이하이미터 (EAR-E101); 이하이미터 (EAR-E102); 이하이미터 (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.

공식 출처

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