FDA 510(k)

MODEL DA-53 PRESSURE GUAGE ISOLATOR

K-Number: K761325 · 1977-01-06

ApplicantExtracorporeal Medical Specialities, Inc.

Decision Date1977-01-06

Product CodeDRS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODEL DA-53 PRESSURE GUAGE ISOLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1977-01-06 under 510(k) number K761325. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL DA-53 PRESSURE GUAGE ISOLATOR?

MODEL DA-53 PRESSURE GUAGE ISOLATOR is a medical device that received FDA 510(k) clearance on 1977-01-06. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K761325.

When did MODEL DA-53 PRESSURE GUAGE ISOLATOR receive FDA 510(k) clearance?

MODEL DA-53 PRESSURE GUAGE ISOLATOR received FDA 510(k) clearance on 1977-01-06, under 510(k) number K761325.

Who is the listed applicant for MODEL DA-53 PRESSURE GUAGE ISOLATOR?

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

What is the FDA product code for MODEL DA-53 PRESSURE GUAGE ISOLATOR?

The FDA product code for MODEL DA-53 PRESSURE GUAGE ISOLATOR is DRS.

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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.