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FDA 510(k)

LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.

K-Number: K863535 · 1987-01-06

ApplicantComputerized Medical Systems, Inc.
Decision Date1987-01-06
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD. 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 1987-01-06 under 510(k) number K863535. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.?

LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD. is a medical device that received FDA 510(k) clearance on 1987-01-06. The listed applicant is Computerized Medical Systems, Inc.. The 510(k) number is K863535.

When did LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD. receive FDA 510(k) clearance?

LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD. received FDA 510(k) clearance on 1987-01-06, under 510(k) number K863535.

Who is the listed applicant for LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.?

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-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.?

The FDA product code for LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD. is DPS.

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Related Devices (Code: DPS)

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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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