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FDA 510(k)

ARCO-MBC, ARCO MC

K-Number: K954171 · 1996-04-30

ApplicantHoll Meditronics, Inc.
Decision Date1996-04-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARCO-MBC, ARCO MC is the device name listed in this FDA 510(k) record. The listed applicant is Holl Meditronics, Inc.. It received FDA 510(k) clearance on 1996-04-30 under 510(k) number K954171. 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 ARCO-MBC, ARCO MC?

ARCO-MBC, ARCO MC is a medical device that received FDA 510(k) clearance on 1996-04-30. The listed applicant is Holl Meditronics, Inc.. The 510(k) number is K954171.

When did ARCO-MBC, ARCO MC receive FDA 510(k) clearance?

ARCO-MBC, ARCO MC received FDA 510(k) clearance on 1996-04-30, under 510(k) number K954171.

Who is the listed applicant for ARCO-MBC, ARCO MC?

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

What is the FDA product code for ARCO-MBC, ARCO MC?

The FDA product code for ARCO-MBC, ARCO MC is GEI.

Other records listing Holl Meditronics, 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.

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Official Source

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