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FDA 510(k)

DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR

K-Number: K981602 · 1998-07-17

ApplicantSunrise Medical Hhg, Inc.
Decision Date1998-07-17
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Medical Hhg, Inc.. It received FDA 510(k) clearance on 1998-07-17 under 510(k) number K981602. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR?

DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR is a medical device that received FDA 510(k) clearance on 1998-07-17. The listed applicant is Sunrise Medical Hhg, Inc.. The 510(k) number is K981602.

When did DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR receive FDA 510(k) clearance?

DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR received FDA 510(k) clearance on 1998-07-17, under 510(k) number K981602.

Who is the listed applicant for DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR?

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

What is the FDA product code for DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR?

The FDA product code for DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR is BTA.

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Other records listing Sunrise Medical Hhg, Inc. as applicant

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Related Devices (Code: BTA)

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.

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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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