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FDA 510(k)

REGULUS MEASUREMENT UNIT

K-Number: K935456 · 1995-10-13

ApplicantCompass Intl., Inc.
Decision Date1995-10-13
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

REGULUS MEASUREMENT UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Compass Intl., Inc.. It received FDA 510(k) clearance on 1995-10-13 under 510(k) number K935456. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGULUS MEASUREMENT UNIT?

REGULUS MEASUREMENT UNIT is a medical device that received FDA 510(k) clearance on 1995-10-13. The listed applicant is Compass Intl., Inc.. The 510(k) number is K935456.

When did REGULUS MEASUREMENT UNIT receive FDA 510(k) clearance?

REGULUS MEASUREMENT UNIT received FDA 510(k) clearance on 1995-10-13, under 510(k) number K935456.

Who is the listed applicant for REGULUS MEASUREMENT UNIT?

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

What is the FDA product code for REGULUS MEASUREMENT UNIT?

The FDA product code for REGULUS MEASUREMENT UNIT is HAW.

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.

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Other records listing Compass Intl., 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.

K964229REGULUS NAVIGATOR

Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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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