FDA 510(k)

MAXI-NEB

K-Number: K852627 · 1985-09-26

Decision Date1985-09-26

Product CodeCCQ

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MAXI-NEB is the device name listed in this FDA 510(k) record. The listed applicant is Ashai Co. , Ltd.. It received FDA 510(k) clearance on 1985-09-26 under 510(k) number K852627. The device is classified under product code CCQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXI-NEB?

MAXI-NEB is a medical device that received FDA 510(k) clearance on 1985-09-26. The listed applicant is Ashai Co. , Ltd.. The 510(k) number is K852627.

When did MAXI-NEB receive FDA 510(k) clearance?

MAXI-NEB received FDA 510(k) clearance on 1985-09-26, under 510(k) number K852627.

Who is the listed applicant for MAXI-NEB?

The FDA 510(k) record lists Ashai Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXI-NEB?

The FDA product code for MAXI-NEB is CCQ.

Other records listing Ashai Co. , Ltd. 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.