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FDA 510(k)

CR-9

K-Number: K821223 · 1982-06-17

ApplicantLife Science Instrumentation, Inc.
Decision Date1982-06-17
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CR-9 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 1982-06-17 under 510(k) number K821223. 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 CR-9?

CR-9 is a medical device that received FDA 510(k) clearance on 1982-06-17. The listed applicant is Life Science Instrumentation, Inc.. The 510(k) number is K821223.

When did CR-9 receive FDA 510(k) clearance?

CR-9 received FDA 510(k) clearance on 1982-06-17, under 510(k) number K821223.

Who is the listed applicant for CR-9?

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 CR-9?

The FDA product code for CR-9 is DRT.

Other records listing Life Science Instrumentation, 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.

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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