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FDA 510(k)

SMARTEMP

K-Number: K991270 · 1999-05-21

ApplicantParkell, Inc.
Decision Date1999-05-21
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SMARTEMP is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 1999-05-21 under 510(k) number K991270. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTEMP?

SMARTEMP is a medical device that received FDA 510(k) clearance on 1999-05-21. The listed applicant is Parkell, Inc.. The 510(k) number is K991270.

When did SMARTEMP receive FDA 510(k) clearance?

SMARTEMP received FDA 510(k) clearance on 1999-05-21, under 510(k) number K991270.

Who is the listed applicant for SMARTEMP?

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

What is the FDA product code for SMARTEMP?

The FDA product code for SMARTEMP is EBG.

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Other records listing Parkell, Inc. as applicant

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Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials 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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