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FDA 510(k)

RITEFLO SPACER

K-Number: K984085 · 1999-08-05

ApplicantAeromax Technologies, Inc.
Decision Date1999-08-05
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RITEFLO SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Aeromax Technologies, Inc.. It received FDA 510(k) clearance on 1999-08-05 under 510(k) number K984085. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RITEFLO SPACER?

RITEFLO SPACER is a medical device that received FDA 510(k) clearance on 1999-08-05. The listed applicant is Aeromax Technologies, Inc.. The 510(k) number is K984085.

When did RITEFLO SPACER receive FDA 510(k) clearance?

RITEFLO SPACER received FDA 510(k) clearance on 1999-08-05, under 510(k) number K984085.

Who is the listed applicant for RITEFLO SPACER?

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

What is the FDA product code for RITEFLO SPACER?

The FDA product code for RITEFLO SPACER is CAF.

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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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