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FDA 510(k)

MEDRAD FLEX INTERFACE DEVICE

K-Number: K971380 · 1997-07-03

ApplicantMedrad, Inc.
Decision Date1997-07-03
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDRAD FLEX INTERFACE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 1997-07-03 under 510(k) number K971380. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDRAD FLEX INTERFACE DEVICE?

MEDRAD FLEX INTERFACE DEVICE is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is Medrad, Inc.. The 510(k) number is K971380.

When did MEDRAD FLEX INTERFACE DEVICE receive FDA 510(k) clearance?

MEDRAD FLEX INTERFACE DEVICE received FDA 510(k) clearance on 1997-07-03, under 510(k) number K971380.

Who is the listed applicant for MEDRAD FLEX INTERFACE DEVICE?

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

What is the FDA product code for MEDRAD FLEX INTERFACE DEVICE?

The FDA product code for MEDRAD FLEX INTERFACE DEVICE is LNH.

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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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