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FDA 510(k)

SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE

K-Number: K936071 · 1994-08-19

ApplicantSmith & Nephew Dyonics, Inc.
Decision Date1994-08-19
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Dyonics, Inc.. It received FDA 510(k) clearance on 1994-08-19 under 510(k) number K936071. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE?

SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1994-08-19. The listed applicant is Smith & Nephew Dyonics, Inc.. The 510(k) number is K936071.

When did SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE receive FDA 510(k) clearance?

SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE received FDA 510(k) clearance on 1994-08-19, under 510(k) number K936071.

Who is the listed applicant for SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE?

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

What is the FDA product code for SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE?

The FDA product code for SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE is HET.

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Other records listing Smith & Nephew Dyonics, Inc. as applicant

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Related Devices (Code: HET)

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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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