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FDA 510(k)

LIFE SCOPE EC, MODEL BSM-1102

K-Number: K000517 · 2000-08-31

ApplicantNihon Kohden America, Inc.
Decision Date2000-08-31
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFE SCOPE EC, MODEL BSM-1102 is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 2000-08-31 under 510(k) number K000517. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFE SCOPE EC, MODEL BSM-1102?

LIFE SCOPE EC, MODEL BSM-1102 is a medical device that received FDA 510(k) clearance on 2000-08-31. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K000517.

When did LIFE SCOPE EC, MODEL BSM-1102 receive FDA 510(k) clearance?

LIFE SCOPE EC, MODEL BSM-1102 received FDA 510(k) clearance on 2000-08-31, under 510(k) number K000517.

Who is the listed applicant for LIFE SCOPE EC, MODEL BSM-1102?

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

What is the FDA product code for LIFE SCOPE EC, MODEL BSM-1102?

The FDA product code for LIFE SCOPE EC, MODEL BSM-1102 is MHX.

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Other records listing Nihon Kohden America, Inc. as applicant

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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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