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FDA 510(k)

SOLO

K-Number: K970523 · 1997-06-03

ApplicantRanger All Season Corp.
Decision Date1997-06-03
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SOLO is the device name listed in this FDA 510(k) record. The listed applicant is Ranger All Season Corp.. It received FDA 510(k) clearance on 1997-06-03 under 510(k) number K970523. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLO?

SOLO is a medical device that received FDA 510(k) clearance on 1997-06-03. The listed applicant is Ranger All Season Corp.. The 510(k) number is K970523.

When did SOLO receive FDA 510(k) clearance?

SOLO received FDA 510(k) clearance on 1997-06-03, under 510(k) number K970523.

Who is the listed applicant for SOLO?

The FDA 510(k) record lists Ranger All Season Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLO?

The FDA product code for SOLO is INI.

Other records listing Ranger All Season Corp. 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.

K011107MODIFICATION TO SOLOK010606SAFARIK970646SAFARI

Related Devices (Code: INI)

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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