FDA 510(k)

AMBULATORY X-12 TELEMETRY MODULE

K-Number: K974149 · 1998-01-08

Decision Date1998-01-08

Product CodeDRG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AMBULATORY X-12 TELEMETRY MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Mortara Instrument, Inc.. It received FDA 510(k) clearance on 1998-01-08 under 510(k) number K974149. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBULATORY X-12 TELEMETRY MODULE?

AMBULATORY X-12 TELEMETRY MODULE is a medical device that received FDA 510(k) clearance on 1998-01-08. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K974149.

When did AMBULATORY X-12 TELEMETRY MODULE receive FDA 510(k) clearance?

AMBULATORY X-12 TELEMETRY MODULE received FDA 510(k) clearance on 1998-01-08, under 510(k) number K974149.

Who is the listed applicant for AMBULATORY X-12 TELEMETRY MODULE?

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

What is the FDA product code for AMBULATORY X-12 TELEMETRY MODULE?

The FDA product code for AMBULATORY X-12 TELEMETRY MODULE is DRG.

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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.