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FDA 510(k)

NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES

K-Number: K971167 · 1997-06-26

ApplicantNeoprobe Corp.
Decision Date1997-06-26
Product CodeIZD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Neoprobe Corp.. It received FDA 510(k) clearance on 1997-06-26 under 510(k) number K971167. The device is classified under product code IZD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES?

NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1997-06-26. The listed applicant is Neoprobe Corp.. The 510(k) number is K971167.

When did NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES receive FDA 510(k) clearance?

NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES received FDA 510(k) clearance on 1997-06-26, under 510(k) number K971167.

Who is the listed applicant for NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES?

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

What is the FDA product code for NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES?

The FDA product code for NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES is IZD.

Related Clinical Trials

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Other records listing Neoprobe 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.

K050088QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZERK962319NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIESK942580NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESK915279NEOPROBE PORTABLE RADIOSCOPE DETECTORK864263NEOPROBE PORTABLE RADIOISOTOPE DETECTOR

Related Devices (Code: IZD)

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.

K123917DECLIPSESPECT VIEWERSurgiceye GmbHK101887CONFIDENT SURGERY SUITE 300, MODEL CSS300Surgiceye GmbHK013751HANDHELD GAMMA FINDER (HGF)Silicon Instruments GmhbK983768MODIFICATION TO GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.K982442C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)Care Wise Medical Products Corp.K961321GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.

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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