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FDA 510(k)

CA, MODEL: CAM

K-Number: K071250 · 2007-09-28

ApplicantOptovue, Inc.
Decision Date2007-09-28
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CA, MODEL: CAM is the device name listed in this FDA 510(k) record. The listed applicant is Optovue, Inc.. It received FDA 510(k) clearance on 2007-09-28 under 510(k) number K071250. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CA, MODEL: CAM?

CA, MODEL: CAM is a medical device that received FDA 510(k) clearance on 2007-09-28. The listed applicant is Optovue, Inc.. The 510(k) number is K071250.

When did CA, MODEL: CAM receive FDA 510(k) clearance?

CA, MODEL: CAM received FDA 510(k) clearance on 2007-09-28, under 510(k) number K071250.

Who is the listed applicant for CA, MODEL: CAM?

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

What is the FDA product code for CA, MODEL: CAM?

The FDA product code for CA, MODEL: CAM is OBO.

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Other records listing Optovue, Inc. as applicant

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.

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Related Devices (Code: OBO)

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.

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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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