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FDA 510(k)

STASIS BUTTON PRSSURE DEVICE

K-Number: K912765 · 1991-08-12

ApplicantArch Development Group
Decision Date1991-08-12
Product CodeMHW
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STASIS BUTTON PRSSURE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Arch Development Group. It received FDA 510(k) clearance on 1991-08-12 under 510(k) number K912765. The device is classified under product code MHW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STASIS BUTTON PRSSURE DEVICE?

STASIS BUTTON PRSSURE DEVICE is a medical device that received FDA 510(k) clearance on 1991-08-12. The listed applicant is Arch Development Group. The 510(k) number is K912765.

When did STASIS BUTTON PRSSURE DEVICE receive FDA 510(k) clearance?

STASIS BUTTON PRSSURE DEVICE received FDA 510(k) clearance on 1991-08-12, under 510(k) number K912765.

Who is the listed applicant for STASIS BUTTON PRSSURE DEVICE?

The FDA 510(k) record lists Arch Development Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STASIS BUTTON PRSSURE DEVICE?

The FDA product code for STASIS BUTTON PRSSURE DEVICE is MHW.

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Other records listing Arch Development Group as applicant

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.

K913047STERILESERT(TM) CABLE AND POLE DRAPE

Related Devices (Code: MHW)

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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