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FDA 510(k)

COSGROVE DEPTH ELECTRODE KIT(CDEK)

K-Number: K961858 · 1996-08-07

ApplicantRadionics, Inc.
Decision Date1996-08-07
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COSGROVE DEPTH ELECTRODE KIT(CDEK) is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1996-08-07 under 510(k) number K961858. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSGROVE DEPTH ELECTRODE KIT(CDEK)?

COSGROVE DEPTH ELECTRODE KIT(CDEK) is a medical device that received FDA 510(k) clearance on 1996-08-07. The listed applicant is Radionics, Inc.. The 510(k) number is K961858.

When did COSGROVE DEPTH ELECTRODE KIT(CDEK) receive FDA 510(k) clearance?

COSGROVE DEPTH ELECTRODE KIT(CDEK) received FDA 510(k) clearance on 1996-08-07, under 510(k) number K961858.

Who is the listed applicant for COSGROVE DEPTH ELECTRODE KIT(CDEK)?

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

What is the FDA product code for COSGROVE DEPTH ELECTRODE KIT(CDEK)?

The FDA product code for COSGROVE DEPTH ELECTRODE KIT(CDEK) is HAW.

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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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