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FDA 510(k)

ACCESSORY TO UNIVERSAL OCTOPAQUE

K-Number: K930357 · 1993-07-13

ApplicantOctostop, Inc.
Decision Date1993-07-13
Product CodeKXH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACCESSORY TO UNIVERSAL OCTOPAQUE is the device name listed in this FDA 510(k) record. The listed applicant is Octostop, Inc.. It received FDA 510(k) clearance on 1993-07-13 under 510(k) number K930357. The device is classified under product code KXH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESSORY TO UNIVERSAL OCTOPAQUE?

ACCESSORY TO UNIVERSAL OCTOPAQUE is a medical device that received FDA 510(k) clearance on 1993-07-13. The listed applicant is Octostop, Inc.. The 510(k) number is K930357.

When did ACCESSORY TO UNIVERSAL OCTOPAQUE receive FDA 510(k) clearance?

ACCESSORY TO UNIVERSAL OCTOPAQUE received FDA 510(k) clearance on 1993-07-13, under 510(k) number K930357.

Who is the listed applicant for ACCESSORY TO UNIVERSAL OCTOPAQUE?

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

What is the FDA product code for ACCESSORY TO UNIVERSAL OCTOPAQUE?

The FDA product code for ACCESSORY TO UNIVERSAL OCTOPAQUE is KXH.

Related Clinical Trials

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Other records listing Octostop, 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.

K972766PIVOTING COMPENSATING FILTERS FOR THE HEADK963941THE PHARAOH COMPENSATING FILTERK953246OCTOROLLK952871RIDGES PLUSK942916OCTOPAQUE UNIVERSALK940306OCTOSTOP COMPENSATING FILTERS

View all 13 devices →

Related Devices (Code: KXH)

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.

K122174PEDIATRIC POSITIONER PAD SETGe Healthcare Coils (Usa Instruments, Inc.)K953246OCTOROLLOctostop, Inc.K930124VARIANT OF OCTOSTOP AND OCTOPAQUEOctostop, Inc.K933134SPECTRUM DG-P7000 PEDIATRIC CRADLESpectrum X-Ray Corp.K884292STRETCHER TABLEFischer Imaging Corp.K863890MAMM-AIREAr Custom Medical Products, Ltd.

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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