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FDA 510(k)

PARALLAX CRANIOSET

K-Number: K994022 · 2000-08-31

ApplicantParallax Medical, Inc.
Decision Date2000-08-31
Product CodeGXP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PARALLAX CRANIOSET is the device name listed in this FDA 510(k) record. The listed applicant is Parallax Medical, Inc.. It received FDA 510(k) clearance on 2000-08-31 under 510(k) number K994022. The device is classified under product code GXP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARALLAX CRANIOSET?

PARALLAX CRANIOSET is a medical device that received FDA 510(k) clearance on 2000-08-31. The listed applicant is Parallax Medical, Inc.. The 510(k) number is K994022.

When did PARALLAX CRANIOSET receive FDA 510(k) clearance?

PARALLAX CRANIOSET received FDA 510(k) clearance on 2000-08-31, under 510(k) number K994022.

Who is the listed applicant for PARALLAX CRANIOSET?

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

What is the FDA product code for PARALLAX CRANIOSET?

The FDA product code for PARALLAX CRANIOSET is GXP.

Related Clinical Trials

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Other records listing Parallax Medical, 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.

K033230TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TAK023445TRACERS BONE CEMENT OPACIFIERK022169CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLESK011206PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLESK991893PARALLAX TRACER RADIOPAQUE PARTICLES

Related Devices (Code: GXP)

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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