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FDA 510(k)

PRESCOTT'S LIGHT SOURCE MODEL NO. II-150

K-Number: K964586 · 1997-01-17

ApplicantIba/Griffith
Decision Date1997-01-17
Product CodeFCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 is the device name listed in this FDA 510(k) record. The listed applicant is Iba/Griffith. It received FDA 510(k) clearance on 1997-01-17 under 510(k) number K964586. The device is classified under product code FCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESCOTT'S LIGHT SOURCE MODEL NO. II-150?

PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 is a medical device that received FDA 510(k) clearance on 1997-01-17. The listed applicant is Iba/Griffith. The 510(k) number is K964586.

When did PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 receive FDA 510(k) clearance?

PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 received FDA 510(k) clearance on 1997-01-17, under 510(k) number K964586.

Who is the listed applicant for PRESCOTT'S LIGHT SOURCE MODEL NO. II-150?

The FDA 510(k) record lists Iba/Griffith as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRESCOTT'S LIGHT SOURCE MODEL NO. II-150?

The FDA product code for PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 is FCW.

Related Clinical Trials

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.

Related Devices (Code: FCW)

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.

Official Source

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