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FDA 510(k)

WESTAR SERIES DENTAL UNITS

K-Number: K082294 · 2008-08-22

ApplicantWestar Medical Products, Inc.
Decision Date2008-08-22
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WESTAR SERIES DENTAL UNITS is the device name listed in this FDA 510(k) record. The listed applicant is Westar Medical Products, Inc.. It received FDA 510(k) clearance on 2008-08-22 under 510(k) number K082294. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WESTAR SERIES DENTAL UNITS?

WESTAR SERIES DENTAL UNITS is a medical device that received FDA 510(k) clearance on 2008-08-22. The listed applicant is Westar Medical Products, Inc.. The 510(k) number is K082294.

When did WESTAR SERIES DENTAL UNITS receive FDA 510(k) clearance?

WESTAR SERIES DENTAL UNITS received FDA 510(k) clearance on 2008-08-22, under 510(k) number K082294.

Who is the listed applicant for WESTAR SERIES DENTAL UNITS?

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

What is the FDA product code for WESTAR SERIES DENTAL UNITS?

The FDA product code for WESTAR SERIES DENTAL UNITS is EIA.

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Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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