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FDA 510(k)

CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1

K-Number: K951193 · 1996-03-13

ApplicantTycos Instruments, Inc.
Decision Date1996-03-13
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1 is the device name listed in this FDA 510(k) record. The listed applicant is Tycos Instruments, Inc.. It received FDA 510(k) clearance on 1996-03-13 under 510(k) number K951193. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1?

CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1 is a medical device that received FDA 510(k) clearance on 1996-03-13. The listed applicant is Tycos Instruments, Inc.. The 510(k) number is K951193.

When did CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1 receive FDA 510(k) clearance?

CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1 received FDA 510(k) clearance on 1996-03-13, under 510(k) number K951193.

Who is the listed applicant for CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1?

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

What is the FDA product code for CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1?

The FDA product code for CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1 is DXN.

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Related Devices (Code: DXN)

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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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