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FDA 510(k)

VITAL SIGNS MONITOR 2

K-Number: K830587 · 1983-06-08

ApplicantPhysio-Control Corp.
Decision Date1983-06-08
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITAL SIGNS MONITOR 2 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 1983-06-08 under 510(k) number K830587. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITAL SIGNS MONITOR 2?

VITAL SIGNS MONITOR 2 is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Physio-Control Corp.. The 510(k) number is K830587.

When did VITAL SIGNS MONITOR 2 receive FDA 510(k) clearance?

VITAL SIGNS MONITOR 2 received FDA 510(k) clearance on 1983-06-08, under 510(k) number K830587.

Who is the listed applicant for VITAL SIGNS MONITOR 2?

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 VITAL SIGNS MONITOR 2?

The FDA product code for VITAL SIGNS MONITOR 2 is DRT.

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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: DRT)

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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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