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)

SWEMAC REISON BIPLANAR 300

K-Number: K911739 · 1991-10-23

ApplicantSeemac Reison AB Co.
Decision Date1991-10-23
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SWEMAC REISON BIPLANAR 300 is the device name listed in this FDA 510(k) record. The listed applicant is Seemac Reison AB Co.. It received FDA 510(k) clearance on 1991-10-23 under 510(k) number K911739. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWEMAC REISON BIPLANAR 300?

SWEMAC REISON BIPLANAR 300 is a medical device that received FDA 510(k) clearance on 1991-10-23. The listed applicant is Seemac Reison AB Co.. The 510(k) number is K911739.

When did SWEMAC REISON BIPLANAR 300 receive FDA 510(k) clearance?

SWEMAC REISON BIPLANAR 300 received FDA 510(k) clearance on 1991-10-23, under 510(k) number K911739.

Who is the listed applicant for SWEMAC REISON BIPLANAR 300?

The FDA 510(k) record lists Seemac Reison AB Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SWEMAC REISON BIPLANAR 300?

The FDA product code for SWEMAC REISON BIPLANAR 300 is OXO.

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

Related Devices (Code: OXO)

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.

K253296Digital C-ARM with 3DAllengers Medical Systems LimitedK252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd.K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, 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.

↑