FDA 510(k)

ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)

K-Number: K970061 · 1997-09-25

Decision Date1997-09-25

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1997-09-25 under 510(k) number K970061. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)?

ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) is a medical device that received FDA 510(k) clearance on 1997-09-25. The listed applicant is Datascope Corp.. The 510(k) number is K970061.

When did ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) receive FDA 510(k) clearance?

ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) received FDA 510(k) clearance on 1997-09-25, under 510(k) number K970061.

Who is the listed applicant for ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)?

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

What is the FDA product code for ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)?

The FDA product code for ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) is DQA.

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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.