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FDA 510(k)

DOLOMITE ROLLATOR

K-Number: K921917 · 1992-05-26

ApplicantSeamark Technologies
Decision Date1992-05-26
Product CodeINM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DOLOMITE ROLLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Seamark Technologies. It received FDA 510(k) clearance on 1992-05-26 under 510(k) number K921917. The device is classified under product code INM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOLOMITE ROLLATOR?

DOLOMITE ROLLATOR is a medical device that received FDA 510(k) clearance on 1992-05-26. The listed applicant is Seamark Technologies. The 510(k) number is K921917.

When did DOLOMITE ROLLATOR receive FDA 510(k) clearance?

DOLOMITE ROLLATOR received FDA 510(k) clearance on 1992-05-26, under 510(k) number K921917.

Who is the listed applicant for DOLOMITE ROLLATOR?

The FDA 510(k) record lists Seamark Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOLOMITE ROLLATOR?

The FDA product code for DOLOMITE ROLLATOR is INM.

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Related Devices (Code: INM)

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.

K063521NISSIN PEDIATRIC SERIES WHEELCHAIRNissin Medical, Inc.K941738STRYKER 5050 STRECHAIRStryker MedicalK941569CAREMOR CLINERWinco, Inc.K933000RECLINING GERI CHAIRS W/CASTERS & LAP TRAYWinco, Inc.K926028BENCHESTheradapt Products, Inc.K926025CHAIRSTheradapt Products, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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