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FDA 510(k)

OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM

K-Number: K950688 · 1996-04-18

ApplicantSafety Tek Corp.
Decision Date1996-04-18
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Safety Tek Corp.. It received FDA 510(k) clearance on 1996-04-18 under 510(k) number K950688. 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 OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM?

OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1996-04-18. The listed applicant is Safety Tek Corp.. The 510(k) number is K950688.

When did OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM receive FDA 510(k) clearance?

OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM received FDA 510(k) clearance on 1996-04-18, under 510(k) number K950688.

Who is the listed applicant for OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM?

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

What is the FDA product code for OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM?

The FDA product code for OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM is DRT.

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Related Devices (Code: DRT)

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

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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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