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FDA 510(k)

MRS-400, MAXI 400, MRSL-400, MAXI 400L

K-Number: K981990 · 1998-06-22

Decision Date1998-06-22
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MRS-400, MAXI 400, MRSL-400, MAXI 400L is the device name listed in this FDA 510(k) record. The listed applicant is D.B.I. America Corp.. It received FDA 510(k) clearance on 1998-06-22 under 510(k) number K981990. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRS-400, MAXI 400, MRSL-400, MAXI 400L?

MRS-400, MAXI 400, MRSL-400, MAXI 400L is a medical device that received FDA 510(k) clearance on 1998-06-22. The listed applicant is D.B.I. America Corp.. The 510(k) number is K981990.

When did MRS-400, MAXI 400, MRSL-400, MAXI 400L receive FDA 510(k) clearance?

MRS-400, MAXI 400, MRSL-400, MAXI 400L received FDA 510(k) clearance on 1998-06-22, under 510(k) number K981990.

Who is the listed applicant for MRS-400, MAXI 400, MRSL-400, MAXI 400L?

The FDA 510(k) record lists D.B.I. America Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRS-400, MAXI 400, MRSL-400, MAXI 400L?

The FDA product code for MRS-400, MAXI 400, MRSL-400, MAXI 400L is EFB.

Other records listing D.B.I. America Corp. 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.

Related Devices (Code: EFB)

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.

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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