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FDA 510(k)

CUFF GUARD

K-Number: K952825 · 1995-09-15

ApplicantBowen Medical Services, Inc.
Decision Date1995-09-15
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CUFF GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Bowen Medical Services, Inc.. It received FDA 510(k) clearance on 1995-09-15 under 510(k) number K952825. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUFF GUARD?

CUFF GUARD is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is Bowen Medical Services, Inc.. The 510(k) number is K952825.

When did CUFF GUARD receive FDA 510(k) clearance?

CUFF GUARD received FDA 510(k) clearance on 1995-09-15, under 510(k) number K952825.

Who is the listed applicant for CUFF GUARD?

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

What is the FDA product code for CUFF GUARD?

The FDA product code for CUFF GUARD is DXQ.

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Related Devices (Code: DXQ)

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

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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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