Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PORT-XP

K-Number: K923359 · 1993-04-07

ApplicantMobile Dental Equipment Corp.
Decision Date1993-04-07
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PORT-XP is the device name listed in this FDA 510(k) record. The listed applicant is Mobile Dental Equipment Corp.. It received FDA 510(k) clearance on 1993-04-07 under 510(k) number K923359. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORT-XP?

PORT-XP is a medical device that received FDA 510(k) clearance on 1993-04-07. The listed applicant is Mobile Dental Equipment Corp.. The 510(k) number is K923359.

When did PORT-XP receive FDA 510(k) clearance?

PORT-XP received FDA 510(k) clearance on 1993-04-07, under 510(k) number K923359.

Who is the listed applicant for PORT-XP?

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

What is the FDA product code for PORT-XP?

The FDA product code for PORT-XP is IZL.

Other records listing Mobile Dental Equipment 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.

K923354PORT OPII, PORT OPIIIK923360PORT-XD

Related Devices (Code: IZL)

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.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom 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.

↑