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FDA 510(k)

VSM R1

K-Number: K842213 · 1984-10-26

ApplicantPhysio-Control Corp.
Decision Date1984-10-26
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VSM R1 is the device name listed in this FDA 510(k) record. The listed applicant is Physio-Control Corp.. It received FDA 510(k) clearance on 1984-10-26 under 510(k) number K842213. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VSM R1?

VSM R1 is a medical device that received FDA 510(k) clearance on 1984-10-26. The listed applicant is Physio-Control Corp.. The 510(k) number is K842213.

When did VSM R1 receive FDA 510(k) clearance?

VSM R1 received FDA 510(k) clearance on 1984-10-26, under 510(k) number K842213.

Who is the listed applicant for VSM R1?

The FDA 510(k) record lists Physio-Control Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VSM R1?

The FDA product code for VSM R1 is DXO.

Other records listing Physio-Control Corp. 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.

K991910LIFEPAK 12 BIPHASICK990338NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEMK983393LIFEPAK 500 BIPHASICK973486LIFE PAK 12K962359LIFEPAK 300K955854LIFEPAK 500

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Related Devices (Code: DXO)

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.

K251367OptoMonitor 3Opsens, Inc.K241418OptoMonitor 3Opsens, Inc.K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLCK202943OptoMonitor 3Opsens, Inc.K193620OptoMonitor 3Opsens, Inc.

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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