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FDA 510(k)

M-10 VENTILATION MONITOR

K-Number: K871139 · 1987-04-21

ApplicantBio-Med Devices, Inc.
Decision Date1987-04-21
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

M-10 VENTILATION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Med Devices, Inc.. It received FDA 510(k) clearance on 1987-04-21 under 510(k) number K871139. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M-10 VENTILATION MONITOR?

M-10 VENTILATION MONITOR is a medical device that received FDA 510(k) clearance on 1987-04-21. The listed applicant is Bio-Med Devices, Inc.. The 510(k) number is K871139.

When did M-10 VENTILATION MONITOR receive FDA 510(k) clearance?

M-10 VENTILATION MONITOR received FDA 510(k) clearance on 1987-04-21, under 510(k) number K871139.

Who is the listed applicant for M-10 VENTILATION MONITOR?

The FDA 510(k) record lists Bio-Med Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M-10 VENTILATION MONITOR?

The FDA product code for M-10 VENTILATION MONITOR is CAP.

Related Clinical Trials

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Other records listing Bio-Med Devices, 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.

K213948OxyMinderK173973TV-100K942938CROSSVENT-4 VENTILATORK896381MVP-10 MRI INFANT VENTILATORK896380IC-2A MRI ADULT/PEDIATRIC VENTILATORK873614CBG CUFF MANOMETER

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Related Devices (Code: CAP)

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.

K201666SINGLE USE MANOMETERFlexicare Medical Limited.K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLCK153733VORTRAN ManometerVortran Medical Technology 1, Inc.K122627GIO DIGITAL PRESSURE GUAGESGalemed Corp.

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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