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FDA 510(k)

UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)

K-Number: K973418 · 1997-10-09

ApplicantAssembly Required Dist., Inc.
Decision Date1997-10-09
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4) is the device name listed in this FDA 510(k) record. The listed applicant is Assembly Required Dist., Inc.. It received FDA 510(k) clearance on 1997-10-09 under 510(k) number K973418. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)?

UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4) is a medical device that received FDA 510(k) clearance on 1997-10-09. The listed applicant is Assembly Required Dist., Inc.. The 510(k) number is K973418.

When did UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4) receive FDA 510(k) clearance?

UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4) received FDA 510(k) clearance on 1997-10-09, under 510(k) number K973418.

Who is the listed applicant for UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)?

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

What is the FDA product code for UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)?

The FDA product code for UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4) is IOR.

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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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