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)

RAFLEX 70

K-Number: K792437 · 1980-01-09

ApplicantMdt Corp., Inc.
Decision Date1980-01-09
Product CodeEAP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RAFLEX 70 is the device name listed in this FDA 510(k) record. The listed applicant is Mdt Corp., Inc.. It received FDA 510(k) clearance on 1980-01-09 under 510(k) number K792437. The device is classified under product code EAP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAFLEX 70?

RAFLEX 70 is a medical device that received FDA 510(k) clearance on 1980-01-09. The listed applicant is Mdt Corp., Inc.. The 510(k) number is K792437.

When did RAFLEX 70 receive FDA 510(k) clearance?

RAFLEX 70 received FDA 510(k) clearance on 1980-01-09, under 510(k) number K792437.

Who is the listed applicant for RAFLEX 70?

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

What is the FDA product code for RAFLEX 70?

The FDA product code for RAFLEX 70 is EAP.

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 Mdt Corp., 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.

K960777MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATORK942485MDT UROLOGY TABLEK942486IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLEK924380MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVEK926081DENTAL LIGHTK924955MDT/HARVEY MC-8 AND MC-10

View all 22 devices →

Related Devices (Code: EAP)

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.

K113360MEDICAL IMAGE PROCESSING UNITHumanray Co,LtdK102573PROVU (TM) DENTAL X-RAY SYSTEMAdvanced Image Science, Inc.K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.K080738DENTRON SENSORDentron Systems, LLCK052422THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)Flow X-Ray Corp.K041385MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, 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.

↑