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FDA 510(k)

LIFE TRACE 40/42

K-Number: K822389 · 1982-09-21

ApplicantLife Science Instrumentation, Inc.
Decision Date1982-09-21
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFE TRACE 40/42 is the device name listed in this FDA 510(k) record. The listed applicant is Life Science Instrumentation, Inc.. It received FDA 510(k) clearance on 1982-09-21 under 510(k) number K822389. 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 TRACE 40/42?

LIFE TRACE 40/42 is a medical device that received FDA 510(k) clearance on 1982-09-21. The listed applicant is Life Science Instrumentation, Inc.. The 510(k) number is K822389.

When did LIFE TRACE 40/42 receive FDA 510(k) clearance?

LIFE TRACE 40/42 received FDA 510(k) clearance on 1982-09-21, under 510(k) number K822389.

Who is the listed applicant for LIFE TRACE 40/42?

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

What is the FDA product code for LIFE TRACE 40/42?

The FDA product code for LIFE TRACE 40/42 is DRT.

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Other records listing Life Science Instrumentation, 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.

K850812EMERGIPACE - EXTERNAL PACEMAKERK842037LS 5K843396LS-260G MONITOR/RECORDER & DEFIBILLATORK840246MINI-DEFIBRILLATOR 280/4K831056DEFIBRILLATOR VPD 545K822617VPD540 DEFIBRILLATOR

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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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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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