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FDA 510(k)

AUTO ENTRY SYSTEM (MATE)

K-Number: K870425 · 1987-03-24

ApplicantKg Engineering, Inc.
Decision Date1987-03-24
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AUTO ENTRY SYSTEM (MATE) is the device name listed in this FDA 510(k) record. The listed applicant is Kg Engineering, Inc.. It received FDA 510(k) clearance on 1987-03-24 under 510(k) number K870425. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO ENTRY SYSTEM (MATE)?

AUTO ENTRY SYSTEM (MATE) is a medical device that received FDA 510(k) clearance on 1987-03-24. The listed applicant is Kg Engineering, Inc.. The 510(k) number is K870425.

When did AUTO ENTRY SYSTEM (MATE) receive FDA 510(k) clearance?

AUTO ENTRY SYSTEM (MATE) received FDA 510(k) clearance on 1987-03-24, under 510(k) number K870425.

Who is the listed applicant for AUTO ENTRY SYSTEM (MATE)?

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

What is the FDA product code for AUTO ENTRY SYSTEM (MATE)?

The FDA product code for AUTO ENTRY SYSTEM (MATE) is IOR.

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 Kg Engineering, Inc. 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.

K854257COMBO 36

Related Devices (Code: IOR)

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.

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbHK261919Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd.K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 Wheelchair (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.K260144Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd.K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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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