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FDA 510(k)

BREEZY SERIES

K-Number: K974820 · 1998-01-27

ApplicantSunrise Medical, Inc.
Decision Date1998-01-27
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BREEZY SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical, Inc.. It received FDA 510(k) clearance on 1998-01-27 under 510(k) number K974820. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREEZY SERIES?

BREEZY SERIES is a medical device that received FDA 510(k) clearance on 1998-01-27. The listed applicant is Sunrise Medical, Inc.. The 510(k) number is K974820.

When did BREEZY SERIES receive FDA 510(k) clearance?

BREEZY SERIES received FDA 510(k) clearance on 1998-01-27, under 510(k) number K974820.

Who is the listed applicant for BREEZY SERIES?

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

What is the FDA product code for BREEZY SERIES?

The FDA product code for BREEZY SERIES is IOR.

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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.

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