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FDA 510(k)

NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30

K-Number: K921319 · 1993-05-05

ApplicantNeuromed, Inc.
Decision Date1993-05-05
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30 is the device name listed in this FDA 510(k) record. The listed applicant is Neuromed, Inc.. It received FDA 510(k) clearance on 1993-05-05 under 510(k) number K921319. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30?

NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30 is a medical device that received FDA 510(k) clearance on 1993-05-05. The listed applicant is Neuromed, Inc.. The 510(k) number is K921319.

When did NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30 receive FDA 510(k) clearance?

NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30 received FDA 510(k) clearance on 1993-05-05, under 510(k) number K921319.

Who is the listed applicant for NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30?

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

What is the FDA product code for NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30?

The FDA product code for NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30 is GZB.

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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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