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FDA 510(k)

PEACE MODEL 100 CUFF MONITOR

K-Number: K912352 · 1991-08-02

ApplicantPeace Medical, Inc.
Decision Date1991-08-02
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PEACE MODEL 100 CUFF MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Peace Medical, Inc.. It received FDA 510(k) clearance on 1991-08-02 under 510(k) number K912352. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEACE MODEL 100 CUFF MONITOR?

PEACE MODEL 100 CUFF MONITOR is a medical device that received FDA 510(k) clearance on 1991-08-02. The listed applicant is Peace Medical, Inc.. The 510(k) number is K912352.

When did PEACE MODEL 100 CUFF MONITOR receive FDA 510(k) clearance?

PEACE MODEL 100 CUFF MONITOR received FDA 510(k) clearance on 1991-08-02, under 510(k) number K912352.

Who is the listed applicant for PEACE MODEL 100 CUFF MONITOR?

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

What is the FDA product code for PEACE MODEL 100 CUFF MONITOR?

The FDA product code for PEACE MODEL 100 CUFF MONITOR is BSK.

Related Clinical Trials

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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Other records listing Peace Medical, Inc. 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.

K902161DEMISTIFIER ISOLATION CHAMBERK853085PAX METER

Related Devices (Code: BSK)

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.

K261499TrachFlushAw Technologies ApsK243562CuffGuardIdmedK242642CuffTrekShanghai Longmann Tech Co., Ltd.K220854TrachCuff Cuff ControllerAw Technologies ApsK221477AG100sHospitech Respiration , Ltd.K202874Puritan Bennett Cuff Pressure ManagerCovidien, LLC

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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