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FDA 510(k)

BLOWER/MISTER

K-Number: K983135 · 1998-11-13

ApplicantCardiothoracic Systems, Inc.
Decision Date1998-11-13
Product CodeFQH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BLOWER/MISTER is the device name listed in this FDA 510(k) record. The listed applicant is Cardiothoracic Systems, Inc.. It received FDA 510(k) clearance on 1998-11-13 under 510(k) number K983135. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOWER/MISTER?

BLOWER/MISTER is a medical device that received FDA 510(k) clearance on 1998-11-13. The listed applicant is Cardiothoracic Systems, Inc.. The 510(k) number is K983135.

When did BLOWER/MISTER receive FDA 510(k) clearance?

BLOWER/MISTER received FDA 510(k) clearance on 1998-11-13, under 510(k) number K983135.

Who is the listed applicant for BLOWER/MISTER?

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

What is the FDA product code for BLOWER/MISTER?

The FDA product code for BLOWER/MISTER is FQH.

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Other records listing Cardiothoracic Systems, Inc. as applicant

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Related Devices (Code: FQH)

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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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