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FDA 510(k)

GALILEO HIGH RESOLUTION MICRO COUPLER

K-Number: K971896 · 1997-10-10

ApplicantNetoptix Corp.
Decision Date1997-10-10
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GALILEO HIGH RESOLUTION MICRO COUPLER is the device name listed in this FDA 510(k) record. The listed applicant is Netoptix Corp.. It received FDA 510(k) clearance on 1997-10-10 under 510(k) number K971896. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALILEO HIGH RESOLUTION MICRO COUPLER?

GALILEO HIGH RESOLUTION MICRO COUPLER is a medical device that received FDA 510(k) clearance on 1997-10-10. The listed applicant is Netoptix Corp.. The 510(k) number is K971896.

When did GALILEO HIGH RESOLUTION MICRO COUPLER receive FDA 510(k) clearance?

GALILEO HIGH RESOLUTION MICRO COUPLER received FDA 510(k) clearance on 1997-10-10, under 510(k) number K971896.

Who is the listed applicant for GALILEO HIGH RESOLUTION MICRO COUPLER?

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

What is the FDA product code for GALILEO HIGH RESOLUTION MICRO COUPLER?

The FDA product code for GALILEO HIGH RESOLUTION MICRO COUPLER is HET.

Related Clinical Trials

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Other records listing Netoptix 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.

K981958LEISEGANG VIDEO COLPOSCOPEK981828GALILEO DISPOSABLE HYSTEROSCOPESK974297GALILEO DISPOSABLE HYSTEROSCOPES

Related Devices (Code: HET)

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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