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)

SPLITSCREEN (ME-975)

K-Number: K971153 · 1997-06-25

ApplicantMerlin Engineering Works, Inc.
Decision Date1997-06-25
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPLITSCREEN (ME-975) is the device name listed in this FDA 510(k) record. The listed applicant is Merlin Engineering Works, Inc.. It received FDA 510(k) clearance on 1997-06-25 under 510(k) number K971153. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPLITSCREEN (ME-975)?

SPLITSCREEN (ME-975) is a medical device that received FDA 510(k) clearance on 1997-06-25. The listed applicant is Merlin Engineering Works, Inc.. The 510(k) number is K971153.

When did SPLITSCREEN (ME-975) receive FDA 510(k) clearance?

SPLITSCREEN (ME-975) received FDA 510(k) clearance on 1997-06-25, under 510(k) number K971153.

Who is the listed applicant for SPLITSCREEN (ME-975)?

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

What is the FDA product code for SPLITSCREEN (ME-975)?

The FDA product code for SPLITSCREEN (ME-975) is LMD.

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 Merlin Engineering Works, 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.

K974882DOWNSCAN LTK971154MULTIPICS(ME-977)K970451DOWNSCAN 120K970450UPSCAN 120K954211CRISPICSK953398UNISCAN

View all 8 devices →

Related Devices (Code: LMD)

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.

K994329IIVS INTEGRATED IMAGE VIEWING STATIONTerarecon,Inc.K992698STENTOR, PAGEVIEWStentor, Inc.K992426RAYPAX WEB CLINICAL SYSTEMSamsung Sds Co., Ltd.K992352ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0Inteleradiology, Inc.K991537SAMSUNG RAYPAX SYSTEMSamsung Sds Co., Ltd.K984000STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEMSurgical Navigation 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.

↑