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FDA 510(k)

ATLANT'S

K-Number: K974395 · 1998-10-22

ApplicantGrad-Line Corp.
Decision Date1998-10-22
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ATLANT'S is the device name listed in this FDA 510(k) record. The listed applicant is Grad-Line Corp.. It received FDA 510(k) clearance on 1998-10-22 under 510(k) number K974395. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATLANT'S?

ATLANT'S is a medical device that received FDA 510(k) clearance on 1998-10-22. The listed applicant is Grad-Line Corp.. The 510(k) number is K974395.

When did ATLANT'S receive FDA 510(k) clearance?

ATLANT'S received FDA 510(k) clearance on 1998-10-22, under 510(k) number K974395.

Who is the listed applicant for ATLANT'S?

The FDA 510(k) record lists Grad-Line Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATLANT'S?

The FDA product code for ATLANT'S is IRP.

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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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