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FDA 510(k)

UP-GRADE AND UP-GRADE PRO

K-Number: K983887 · 1999-02-12

ApplicantMedisim, Ltd.
Decision Date1999-02-12
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UP-GRADE AND UP-GRADE PRO is the device name listed in this FDA 510(k) record. The listed applicant is Medisim, Ltd.. It received FDA 510(k) clearance on 1999-02-12 under 510(k) number K983887. 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 UP-GRADE AND UP-GRADE PRO?

UP-GRADE AND UP-GRADE PRO is a medical device that received FDA 510(k) clearance on 1999-02-12. The listed applicant is Medisim, Ltd.. The 510(k) number is K983887.

When did UP-GRADE AND UP-GRADE PRO receive FDA 510(k) clearance?

UP-GRADE AND UP-GRADE PRO received FDA 510(k) clearance on 1999-02-12, under 510(k) number K983887.

Who is the listed applicant for UP-GRADE AND UP-GRADE PRO?

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

What is the FDA product code for UP-GRADE AND UP-GRADE PRO?

The FDA product code for UP-GRADE AND UP-GRADE PRO is FLL.

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Other records listing Medisim, Ltd. 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.

K131155UGFT3; FHT7K090386NON-INVASIVE INFRARED (NIR)K051422DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICEK032362UP-GRADE FOREHEAD THERMOMETERK012217M5T INSTANT FEVER THERMOMETER

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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