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FDA 510(k)

ROTA DATAMATE I

K-Number: K935945 · 1994-04-19

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

Device Summary

ROTA DATAMATE I is the device name listed in this FDA 510(k) record. The listed applicant is Rota Systems,Inc.. It received FDA 510(k) clearance on 1994-04-19 under 510(k) number K935945. 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 DATAMATE I?

ROTA DATAMATE I is a medical device that received FDA 510(k) clearance on 1994-04-19. The listed applicant is Rota Systems,Inc.. The 510(k) number is K935945.

When did ROTA DATAMATE I receive FDA 510(k) clearance?

ROTA DATAMATE I received FDA 510(k) clearance on 1994-04-19, under 510(k) number K935945.

Who is the listed applicant for ROTA DATAMATE I?

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

What is the FDA product code for ROTA DATAMATE I?

The FDA product code for ROTA DATAMATE I is HMF.

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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.

K935952ROTA SYSTEM 5000Rota Systems Medfurniture, 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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