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FDA 510(k)

ACU-SIZER(TM)

K-Number: K941011 · 1994-06-13

ApplicantApplied Medical Resources
Decision Date1994-06-13
Product CodeEYB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACU-SIZER(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 1994-06-13 under 510(k) number K941011. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACU-SIZER(TM)?

ACU-SIZER(TM) is a medical device that received FDA 510(k) clearance on 1994-06-13. The listed applicant is Applied Medical Resources. The 510(k) number is K941011.

When did ACU-SIZER(TM) receive FDA 510(k) clearance?

ACU-SIZER(TM) received FDA 510(k) clearance on 1994-06-13, under 510(k) number K941011.

Who is the listed applicant for ACU-SIZER(TM)?

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

What is the FDA product code for ACU-SIZER(TM)?

The FDA product code for ACU-SIZER(TM) is EYB.

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Related Devices (Code: EYB)

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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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