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FDA 510(k)

ROTA SYSTEM 5000

K-Number: K935952 · 1994-04-19

ApplicantRota Systems Medfurniture, Inc.
Decision Date1994-04-19
Product CodeHMF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ROTA SYSTEM 5000 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 1994-04-19 under 510(k) number K935952. 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 5000?

ROTA SYSTEM 5000 is a medical device that received FDA 510(k) clearance on 1994-04-19. The listed applicant is Rota Systems Medfurniture, Inc.. The 510(k) number is K935952.

When did ROTA SYSTEM 5000 receive FDA 510(k) clearance?

ROTA SYSTEM 5000 received FDA 510(k) clearance on 1994-04-19, under 510(k) number K935952.

Who is the listed applicant for ROTA SYSTEM 5000?

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 5000?

The FDA product code for ROTA SYSTEM 5000 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.

K931839ROTA SYSTEM XL

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.K931839ROTA SYSTEM XLRota Systems Medfurniture, Inc.K930440MARCO INTERNATIONAL STANDMarco Ophthalmic, Inc.K924771BURTON OPHTHALMIC STAND - MODEL XL3200R.H. Burton Co.K924780BURTON OPHTHALMIC EXAM UNIT - MODEL 2201R.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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