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FDA 510(k)

SYSTEM VI MONITOR

K-Number: K874326 · 1988-12-05

ApplicantAir-Shields, Inc.
Decision Date1988-12-05
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYSTEM VI MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Air-Shields, Inc.. It received FDA 510(k) clearance on 1988-12-05 under 510(k) number K874326. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM VI MONITOR?

SYSTEM VI MONITOR is a medical device that received FDA 510(k) clearance on 1988-12-05. The listed applicant is Air-Shields, Inc.. The 510(k) number is K874326.

When did SYSTEM VI MONITOR receive FDA 510(k) clearance?

SYSTEM VI MONITOR received FDA 510(k) clearance on 1988-12-05, under 510(k) number K874326.

Who is the listed applicant for SYSTEM VI MONITOR?

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

What is the FDA product code for SYSTEM VI MONITOR?

The FDA product code for SYSTEM VI MONITOR is DPS.

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Other records listing Air-Shields, 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.

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Related Devices (Code: DPS)

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

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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