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FDA 510(k)

AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN

K-Number: K932403 · 1994-02-24

ApplicantMedrad, Inc.
Decision Date1994-02-24
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 1994-02-24 under 510(k) number K932403. 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 AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN?

AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN is a medical device that received FDA 510(k) clearance on 1994-02-24. The listed applicant is Medrad, Inc.. The 510(k) number is K932403.

When did AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN receive FDA 510(k) clearance?

AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN received FDA 510(k) clearance on 1994-02-24, under 510(k) number K932403.

Who is the listed applicant for AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN?

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 AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN?

The FDA product code for AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN is LNH.

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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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