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FDA 510(k)

500 INFUSER

K-Number: K914988 · 1992-04-06

ApplicantExcel Medical, Inc.
Decision Date1992-04-06
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

500 INFUSER is the device name listed in this FDA 510(k) record. The listed applicant is Excel Medical, Inc.. It received FDA 510(k) clearance on 1992-04-06 under 510(k) number K914988. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 500 INFUSER?

500 INFUSER is a medical device that received FDA 510(k) clearance on 1992-04-06. The listed applicant is Excel Medical, Inc.. The 510(k) number is K914988.

When did 500 INFUSER receive FDA 510(k) clearance?

500 INFUSER received FDA 510(k) clearance on 1992-04-06, under 510(k) number K914988.

Who is the listed applicant for 500 INFUSER?

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

What is the FDA product code for 500 INFUSER?

The FDA product code for 500 INFUSER is FRN.

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Other records listing Excel Medical, 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.

K932462VENTED NEEDLEK923966SYRINGE ADAPTORK913804EXCELSIOR SINGLE LEAD DISPENSING SETK905116PHARM-ASSIST

Related Devices (Code: FRN)

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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.

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