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)

MODIFICATION TO IMTEC SENDAX MDI

K-Number: K990983 · 1999-04-13

ApplicantImtec Corp.
Decision Date1999-04-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO IMTEC SENDAX MDI is the device name listed in this FDA 510(k) record. The listed applicant is Imtec Corp.. It received FDA 510(k) clearance on 1999-04-13 under 510(k) number K990983. 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 MODIFICATION TO IMTEC SENDAX MDI?

MODIFICATION TO IMTEC SENDAX MDI is a medical device that received FDA 510(k) clearance on 1999-04-13. The listed applicant is Imtec Corp.. The 510(k) number is K990983.

When did MODIFICATION TO IMTEC SENDAX MDI receive FDA 510(k) clearance?

MODIFICATION TO IMTEC SENDAX MDI received FDA 510(k) clearance on 1999-04-13, under 510(k) number K990983.

Who is the listed applicant for MODIFICATION TO IMTEC SENDAX MDI?

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

What is the FDA product code for MODIFICATION TO IMTEC SENDAX MDI?

The FDA product code for MODIFICATION TO IMTEC SENDAX MDI is DZE.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Imtec 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.

K081653MDI MII ONE-PIECE IMPLANT, 2.9MMK081347ILUMA VISIONK072660ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114K053046ILUMA ORTHOCAT/DENTALCATK043226ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320K042289MDI ORTHO

View all 28 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑