FDA 510(k)

ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES

K-Number: K973190 · 1997-11-21

Decision Date1997-11-21

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Cryomedical Sciences, Inc.. It received FDA 510(k) clearance on 1997-11-21 under 510(k) number K973190. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES?

ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES is a medical device that received FDA 510(k) clearance on 1997-11-21. The listed applicant is Cryomedical Sciences, Inc.. The 510(k) number is K973190.

When did ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES receive FDA 510(k) clearance?

ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES received FDA 510(k) clearance on 1997-11-21, under 510(k) number K973190.

Who is the listed applicant for ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES?

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

What is the FDA product code for ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES?

The FDA product code for ACCUPROBE 450, ACCUPROBE 550/530 AND THE ACCUPROBE 600 SERIES is GEI.

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Other records listing Cryomedical Sciences, Inc. as applicant

K011073CRYOPLAN SYSTEM K982055ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880 K980668CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790 K980670CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722 K970995CMS CRYOLITE K964336CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680

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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.