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FDA 510(k)

LIFEWATCH(R) PORTABLE MONITORING SYSTEM

K-Number: K864419 · 1987-03-16

ApplicantLifewatch Systems, Inc.
Decision Date1987-03-16
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LIFEWATCH(R) PORTABLE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lifewatch Systems, Inc.. It received FDA 510(k) clearance on 1987-03-16 under 510(k) number K864419. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFEWATCH(R) PORTABLE MONITORING SYSTEM?

LIFEWATCH(R) PORTABLE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1987-03-16. The listed applicant is Lifewatch Systems, Inc.. The 510(k) number is K864419.

When did LIFEWATCH(R) PORTABLE MONITORING SYSTEM receive FDA 510(k) clearance?

LIFEWATCH(R) PORTABLE MONITORING SYSTEM received FDA 510(k) clearance on 1987-03-16, under 510(k) number K864419.

Who is the listed applicant for LIFEWATCH(R) PORTABLE MONITORING SYSTEM?

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

What is the FDA product code for LIFEWATCH(R) PORTABLE MONITORING SYSTEM?

The FDA product code for LIFEWATCH(R) PORTABLE MONITORING SYSTEM is BZQ.

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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Other records listing Lifewatch Systems, Inc. as applicant

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.

K864487LIFEWATCH SENSOR BELTK854705INFAGUARD TM

Related Devices (Code: BZQ)

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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Official Source

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