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FDA 510(k)

ACCURATECARE I & ACCURATECARE II

K-Number: K851511 · 1985-07-01

ApplicantSunnex, Inc.
Decision Date1985-07-01
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACCURATECARE I & ACCURATECARE II is the device name listed in this FDA 510(k) record. The listed applicant is Sunnex, Inc.. It received FDA 510(k) clearance on 1985-07-01 under 510(k) number K851511. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCURATECARE I & ACCURATECARE II?

ACCURATECARE I & ACCURATECARE II is a medical device that received FDA 510(k) clearance on 1985-07-01. The listed applicant is Sunnex, Inc.. The 510(k) number is K851511.

When did ACCURATECARE I & ACCURATECARE II receive FDA 510(k) clearance?

ACCURATECARE I & ACCURATECARE II received FDA 510(k) clearance on 1985-07-01, under 510(k) number K851511.

Who is the listed applicant for ACCURATECARE I & ACCURATECARE II?

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

What is the FDA product code for ACCURATECARE I & ACCURATECARE II?

The FDA product code for ACCURATECARE I & ACCURATECARE II is GZJ.

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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.

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