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FDA 510(k)

MOBIMED SYSTEM, (PEGASUS AND POLARIS)

K-Number: K973318 · 1998-02-19

ApplicantOrtivus Us, Inc.
Decision Date1998-02-19
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MOBIMED SYSTEM, (PEGASUS AND POLARIS) is the device name listed in this FDA 510(k) record. The listed applicant is Ortivus Us, Inc.. It received FDA 510(k) clearance on 1998-02-19 under 510(k) number K973318. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBIMED SYSTEM, (PEGASUS AND POLARIS)?

MOBIMED SYSTEM, (PEGASUS AND POLARIS) is a medical device that received FDA 510(k) clearance on 1998-02-19. The listed applicant is Ortivus Us, Inc.. The 510(k) number is K973318.

When did MOBIMED SYSTEM, (PEGASUS AND POLARIS) receive FDA 510(k) clearance?

MOBIMED SYSTEM, (PEGASUS AND POLARIS) received FDA 510(k) clearance on 1998-02-19, under 510(k) number K973318.

Who is the listed applicant for MOBIMED SYSTEM, (PEGASUS AND POLARIS)?

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

What is the FDA product code for MOBIMED SYSTEM, (PEGASUS AND POLARIS)?

The FDA product code for MOBIMED SYSTEM, (PEGASUS AND POLARIS) is MSX.

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Related Devices (Code: MSX)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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