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FDA 510(k)

NERVE FIBER ANALYZER

K-Number: K941705 · 1994-07-18

ApplicantCarl Zeiss Meditec, Inc.
Decision Date1994-07-18
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NERVE FIBER ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 1994-07-18 under 510(k) number K941705. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NERVE FIBER ANALYZER?

NERVE FIBER ANALYZER is a medical device that received FDA 510(k) clearance on 1994-07-18. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K941705.

When did NERVE FIBER ANALYZER receive FDA 510(k) clearance?

NERVE FIBER ANALYZER received FDA 510(k) clearance on 1994-07-18, under 510(k) number K941705.

Who is the listed applicant for NERVE FIBER ANALYZER?

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

What is the FDA product code for NERVE FIBER ANALYZER?

The FDA product code for NERVE FIBER ANALYZER is HLI.

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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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