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FDA 510(k)

PHYSICAL MONITORING REGISTRATION UNIT

K-Number: K022719 · 2002-11-13

ApplicantMaryrose Cusimano, Ph.D./Phil Reaston
Decision Date2002-11-13
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PHYSICAL MONITORING REGISTRATION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Maryrose Cusimano, Ph.D./Phil Reaston. It received FDA 510(k) clearance on 2002-11-13 under 510(k) number K022719. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHYSICAL MONITORING REGISTRATION UNIT?

PHYSICAL MONITORING REGISTRATION UNIT is a medical device that received FDA 510(k) clearance on 2002-11-13. The listed applicant is Maryrose Cusimano, Ph.D./Phil Reaston. The 510(k) number is K022719.

When did PHYSICAL MONITORING REGISTRATION UNIT receive FDA 510(k) clearance?

PHYSICAL MONITORING REGISTRATION UNIT received FDA 510(k) clearance on 2002-11-13, under 510(k) number K022719.

Who is the listed applicant for PHYSICAL MONITORING REGISTRATION UNIT?

The FDA 510(k) record lists Maryrose Cusimano, Ph.D./Phil Reaston as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHYSICAL MONITORING REGISTRATION UNIT?

The FDA product code for PHYSICAL MONITORING REGISTRATION UNIT is IKN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: IKN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, Inc.

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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