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FDA 510(k)

SHERIDAN - YSI/ECG SONATEMP (TM)

K-Number: K861541 · 1986-06-16

ApplicantSheridan Catheter Corp.
Decision Date1986-06-16
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SHERIDAN - YSI/ECG SONATEMP (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Sheridan Catheter Corp.. It received FDA 510(k) clearance on 1986-06-16 under 510(k) number K861541. The device is classified under product code BZT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHERIDAN - YSI/ECG SONATEMP (TM)?

SHERIDAN - YSI/ECG SONATEMP (TM) is a medical device that received FDA 510(k) clearance on 1986-06-16. The listed applicant is Sheridan Catheter Corp.. The 510(k) number is K861541.

When did SHERIDAN - YSI/ECG SONATEMP (TM) receive FDA 510(k) clearance?

SHERIDAN - YSI/ECG SONATEMP (TM) received FDA 510(k) clearance on 1986-06-16, under 510(k) number K861541.

Who is the listed applicant for SHERIDAN - YSI/ECG SONATEMP (TM)?

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

What is the FDA product code for SHERIDAN - YSI/ECG SONATEMP (TM)?

The FDA product code for SHERIDAN - YSI/ECG SONATEMP (TM) is BZT.

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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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