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FDA 510(k)

MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1

K-Number: K982746 · 1998-09-14

ApplicantNew Deantronics Taiwan , Ltd.
Decision Date1998-09-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1 is the device name listed in this FDA 510(k) record. The listed applicant is New Deantronics Taiwan , Ltd.. It received FDA 510(k) clearance on 1998-09-14 under 510(k) number K982746. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1?

MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1 is a medical device that received FDA 510(k) clearance on 1998-09-14. The listed applicant is New Deantronics Taiwan , Ltd.. The 510(k) number is K982746.

When did MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1 receive FDA 510(k) clearance?

MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1 received FDA 510(k) clearance on 1998-09-14, under 510(k) number K982746.

Who is the listed applicant for MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1?

The FDA 510(k) record lists New Deantronics Taiwan , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1?

The FDA product code for MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1 is GEI.

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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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