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FDA 510(k)

OCTOPAQUE UNIVERSAL

K-Number: K942916 · 1994-09-08

ApplicantOctostop, Inc.
Decision Date1994-09-08
Product CodeIXQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OCTOPAQUE UNIVERSAL is the device name listed in this FDA 510(k) record. The listed applicant is Octostop, Inc.. It received FDA 510(k) clearance on 1994-09-08 under 510(k) number K942916. The device is classified under product code IXQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCTOPAQUE UNIVERSAL?

OCTOPAQUE UNIVERSAL is a medical device that received FDA 510(k) clearance on 1994-09-08. The listed applicant is Octostop, Inc.. The 510(k) number is K942916.

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

OCTOPAQUE UNIVERSAL received FDA 510(k) clearance on 1994-09-08, under 510(k) number K942916.

Who is the listed applicant for OCTOPAQUE UNIVERSAL?

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 OCTOPAQUE UNIVERSAL?

The FDA product code for OCTOPAQUE UNIVERSAL is IXQ.

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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 PLUSK940306OCTOSTOP COMPENSATING FILTERSK935444OCTOSTOP(R) CHAIR (NEW MODEL

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Related Devices (Code: IXQ)

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.

K973842CARBON FIBER CONFORMAL COUCH TOPMedtec, Inc.K960083MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300Wuestec Medical, Inc.K954225MED-TEC HAND GRIPMedtec, Inc.K946262EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLESScott Imaging Intl., Inc.K942190ID100 MOBILE FLUOROSCOPIC EXAMINING TABLEImage Diagnostics, Inc.K913425DIAL-A-RAD PORTA RAD TABLEDial-A-Rad

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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