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FDA 510(k)

NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER

K-Number: K946175 · 1995-11-22

ApplicantNihon Kohden America, Inc.
Decision Date1995-11-22
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER 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 1995-11-22 under 510(k) number K946175. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER?

NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER is a medical device that received FDA 510(k) clearance on 1995-11-22. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K946175.

When did NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER receive FDA 510(k) clearance?

NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER received FDA 510(k) clearance on 1995-11-22, under 510(k) number K946175.

Who is the listed applicant for NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER?

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 NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER?

The FDA product code for NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER is DRG.

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Other records listing Nihon Kohden America, 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.

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Related Devices (Code: DRG)

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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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