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FDA 510(k)

SPECTRUM SPIRIT

K-Number: K983763 · 1998-11-23

ApplicantFreedom Designs, Inc.
Decision Date1998-11-23
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPECTRUM SPIRIT is the device name listed in this FDA 510(k) record. The listed applicant is Freedom Designs, Inc.. It received FDA 510(k) clearance on 1998-11-23 under 510(k) number K983763. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM SPIRIT?

SPECTRUM SPIRIT is a medical device that received FDA 510(k) clearance on 1998-11-23. The listed applicant is Freedom Designs, Inc.. The 510(k) number is K983763.

When did SPECTRUM SPIRIT receive FDA 510(k) clearance?

SPECTRUM SPIRIT received FDA 510(k) clearance on 1998-11-23, under 510(k) number K983763.

Who is the listed applicant for SPECTRUM SPIRIT?

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

What is the FDA product code for SPECTRUM SPIRIT?

The FDA product code for SPECTRUM SPIRIT is IOR.

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Other records listing Freedom Designs, 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: IOR)

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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