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FDA 510(k)

LIFE-WATCH MONITOR LT-8

K-Number: K863534 · 1986-11-21

ApplicantComputerized Medical Systems, Inc.
Decision Date1986-11-21
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFE-WATCH MONITOR LT-8 is the device name listed in this FDA 510(k) record. The listed applicant is Computerized Medical Systems, Inc.. It received FDA 510(k) clearance on 1986-11-21 under 510(k) number K863534. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFE-WATCH MONITOR LT-8?

LIFE-WATCH MONITOR LT-8 is a medical device that received FDA 510(k) clearance on 1986-11-21. The listed applicant is Computerized Medical Systems, Inc.. The 510(k) number is K863534.

When did LIFE-WATCH MONITOR LT-8 receive FDA 510(k) clearance?

LIFE-WATCH MONITOR LT-8 received FDA 510(k) clearance on 1986-11-21, under 510(k) number K863534.

Who is the listed applicant for LIFE-WATCH MONITOR LT-8?

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

What is the FDA product code for LIFE-WATCH MONITOR LT-8?

The FDA product code for LIFE-WATCH MONITOR LT-8 is DRT.

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Other records listing Computerized Medical Systems, Inc. as applicant

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Related Devices (Code: DRT)

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

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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