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FDA 510(k)

ROTA SYSTEM XL

K-Number: K931839 · 1993-11-22

ApplicantRota Systems Medfurniture, Inc.
Decision Date1993-11-22
Product CodeHMF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ROTA SYSTEM XL is the device name listed in this FDA 510(k) record. The listed applicant is Rota Systems Medfurniture, Inc.. It received FDA 510(k) clearance on 1993-11-22 under 510(k) number K931839. The device is classified under product code HMF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTA SYSTEM XL?

ROTA SYSTEM XL is a medical device that received FDA 510(k) clearance on 1993-11-22. The listed applicant is Rota Systems Medfurniture, Inc.. The 510(k) number is K931839.

When did ROTA SYSTEM XL receive FDA 510(k) clearance?

ROTA SYSTEM XL received FDA 510(k) clearance on 1993-11-22, under 510(k) number K931839.

Who is the listed applicant for ROTA SYSTEM XL?

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

What is the FDA product code for ROTA SYSTEM XL?

The FDA product code for ROTA SYSTEM XL is HMF.

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 Rota Systems Medfurniture, 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.

K935952ROTA SYSTEM 5000

Related Devices (Code: HMF)

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.

K935945ROTA DATAMATE IRota Systems,Inc.K935952ROTA SYSTEM 5000Rota Systems Medfurniture, Inc.K930440MARCO INTERNATIONAL STANDMarco Ophthalmic, Inc.K924780BURTON OPHTHALMIC EXAM UNIT - MODEL 2201R.H. Burton Co.K924771BURTON OPHTHALMIC STAND - MODEL XL3200R.H. Burton Co.K913961OPHTHALMIC STANDLuneau Ophtalmologie SA

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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