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FDA 510(k)

MODEL 2100 PORTABLE FIELD UNIT

K-Number: K911506 · 1991-06-24

ApplicantDntl Corp.
Decision Date1991-06-24
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODEL 2100 PORTABLE FIELD UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Dntl Corp.. It received FDA 510(k) clearance on 1991-06-24 under 510(k) number K911506. 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 MODEL 2100 PORTABLE FIELD UNIT?

MODEL 2100 PORTABLE FIELD UNIT is a medical device that received FDA 510(k) clearance on 1991-06-24. The listed applicant is Dntl Corp.. The 510(k) number is K911506.

When did MODEL 2100 PORTABLE FIELD UNIT receive FDA 510(k) clearance?

MODEL 2100 PORTABLE FIELD UNIT received FDA 510(k) clearance on 1991-06-24, under 510(k) number K911506.

Who is the listed applicant for MODEL 2100 PORTABLE FIELD UNIT?

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

What is the FDA product code for MODEL 2100 PORTABLE FIELD UNIT?

The FDA product code for MODEL 2100 PORTABLE FIELD UNIT is EIA.

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 Dntl 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.

K912400MOBILE X-RAY FLOOR STANDK883775PORTABLE II DENTAL DELIVERY SYSTEM

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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