FDA 510(k)

MAMM-AIRE

K-Number: K863890 · 1986-10-14

ApplicantAr Custom Medical Products, Ltd.

Decision Date1986-10-14

Product CodeKXH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MAMM-AIRE is the device name listed in this FDA 510(k) record. The listed applicant is Ar Custom Medical Products, Ltd.. It received FDA 510(k) clearance on 1986-10-14 under 510(k) number K863890. The device is classified under product code KXH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAMM-AIRE?

MAMM-AIRE is a medical device that received FDA 510(k) clearance on 1986-10-14. The listed applicant is Ar Custom Medical Products, Ltd.. The 510(k) number is K863890.

When did MAMM-AIRE receive FDA 510(k) clearance?

MAMM-AIRE received FDA 510(k) clearance on 1986-10-14, under 510(k) number K863890.

Who is the listed applicant for MAMM-AIRE?

The FDA 510(k) record lists Ar Custom Medical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAMM-AIRE?

The FDA product code for MAMM-AIRE is KXH.

Related Devices (Code: KXH)

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.

K122174PEDIATRIC POSITIONER PAD SETGe Healthcare Coils (Usa Instruments, Inc.)K953246OCTOROLLOctostop, Inc.K930124VARIANT OF OCTOSTOP AND OCTOPAQUEOctostop, Inc.K933134SPECTRUM DG-P7000 PEDIATRIC CRADLESpectrum X-Ray Corp.K930357ACCESSORY TO UNIVERSAL OCTOPAQUEOctostop, Inc.K884292STRETCHER TABLEFischer Imaging Corp.

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.