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FDA 510(k)

MONORAIL

K-Number: K040143 · 2004-09-13

ApplicantNats Corp.
Decision Date2004-09-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MONORAIL is the device name listed in this FDA 510(k) record. The listed applicant is Nats Corp.. It received FDA 510(k) clearance on 2004-09-13 under 510(k) number K040143. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONORAIL?

MONORAIL is a medical device that received FDA 510(k) clearance on 2004-09-13. The listed applicant is Nats Corp.. The 510(k) number is K040143.

When did MONORAIL receive FDA 510(k) clearance?

MONORAIL received FDA 510(k) clearance on 2004-09-13, under 510(k) number K040143.

Who is the listed applicant for MONORAIL?

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

What is the FDA product code for MONORAIL?

The FDA product code for MONORAIL is DZE.

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Other records listing Nats 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.

K033142POWERED WHEELCHAIRK020060ASTOFLOK011820DENTORIUM CONVERTIBLE ACRYLICK991184HYDROTONE-THERMAL CAPSULE SYSTEM

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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