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FDA 510(k)

PACIFICA

K-Number: K073407 · 2008-02-28

ApplicantOr-Nim Medical , Ltd.
Decision Date2008-02-28
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PACIFICA is the device name listed in this FDA 510(k) record. The listed applicant is Or-Nim Medical , Ltd.. It received FDA 510(k) clearance on 2008-02-28 under 510(k) number K073407. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACIFICA?

PACIFICA is a medical device that received FDA 510(k) clearance on 2008-02-28. The listed applicant is Or-Nim Medical , Ltd.. The 510(k) number is K073407.

When did PACIFICA receive FDA 510(k) clearance?

PACIFICA received FDA 510(k) clearance on 2008-02-28, under 510(k) number K073407.

Who is the listed applicant for PACIFICA?

The FDA 510(k) record lists Or-Nim Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACIFICA?

The FDA product code for PACIFICA is MUD.

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Other records listing Or-Nim Medical , Ltd. 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: MUD)

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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