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FDA 510(k)

OTO-CEM

K-Number: K011338 · 2001-09-13

ApplicantOtotech, Inc.
Decision Date2001-09-13
Product CodeNEA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OTO-CEM is the device name listed in this FDA 510(k) record. The listed applicant is Ototech, Inc.. It received FDA 510(k) clearance on 2001-09-13 under 510(k) number K011338. The device is classified under product code NEA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTO-CEM?

OTO-CEM is a medical device that received FDA 510(k) clearance on 2001-09-13. The listed applicant is Ototech, Inc.. The 510(k) number is K011338.

When did OTO-CEM receive FDA 510(k) clearance?

OTO-CEM received FDA 510(k) clearance on 2001-09-13, under 510(k) number K011338.

Who is the listed applicant for OTO-CEM?

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

What is the FDA product code for OTO-CEM?

The FDA product code for OTO-CEM is NEA.

Related Devices (Code: NEA)

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.

K080032ENVOYCEM, MODEL 1640Envoy Medical CorporationK060750STRYKER INJECTABLE CEMENTStryker CmfK042516OTOMIMIXWalter Lorenz Surgical, Inc.K003567SERENOCEM, MODEL BC 010Corinthian Medical , Ltd.

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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