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FDA 510(k)

CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999

K-Number: K993950 · 2000-08-23

ApplicantNien Made Electrnics Corp.
Decision Date2000-08-23
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999 is the device name listed in this FDA 510(k) record. The listed applicant is Nien Made Electrnics Corp.. It received FDA 510(k) clearance on 2000-08-23 under 510(k) number K993950. 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 CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999?

CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999 is a medical device that received FDA 510(k) clearance on 2000-08-23. The listed applicant is Nien Made Electrnics Corp.. The 510(k) number is K993950.

When did CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999 receive FDA 510(k) clearance?

CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999 received FDA 510(k) clearance on 2000-08-23, under 510(k) number K993950.

Who is the listed applicant for CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999?

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

What is the FDA product code for CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999?

The FDA product code for CECILIA PENGUIN MULTI-USE THERMOMETER, MODEL HP-ETO9999 is FLL.

Related Clinical Trials

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.

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Other records listing Nien Made Electrnics Corp. 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.

K011310NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1

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.

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Official Source

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