FDA 510(k)

MODIFICATION OF: RHEO DOPPLEX II

K-Number: K984307 · 1999-01-12

Decision Date1999-01-12

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF: RHEO DOPPLEX II is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare, Inc.. It received FDA 510(k) clearance on 1999-01-12 under 510(k) number K984307. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION OF: RHEO DOPPLEX II?

MODIFICATION OF: RHEO DOPPLEX II is a medical device that received FDA 510(k) clearance on 1999-01-12. The listed applicant is Huntleigh Healthcare, Inc.. The 510(k) number is K984307.

When did MODIFICATION OF: RHEO DOPPLEX II receive FDA 510(k) clearance?

MODIFICATION OF: RHEO DOPPLEX II received FDA 510(k) clearance on 1999-01-12, under 510(k) number K984307.

Who is the listed applicant for MODIFICATION OF: RHEO DOPPLEX II?

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

What is the FDA product code for MODIFICATION OF: RHEO DOPPLEX II?

The FDA product code for MODIFICATION OF: RHEO DOPPLEX II is IYN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.