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FDA 510(k)

MODIFIED BIOLOG

K-Number: K915624 · 1992-03-27

ApplicantMicromedical Industries, Ltd.
Decision Date1992-03-27
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED BIOLOG is the device name listed in this FDA 510(k) record. The listed applicant is Micromedical Industries, Ltd.. It received FDA 510(k) clearance on 1992-03-27 under 510(k) number K915624. 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 MODIFIED BIOLOG?

MODIFIED BIOLOG is a medical device that received FDA 510(k) clearance on 1992-03-27. The listed applicant is Micromedical Industries, Ltd.. The 510(k) number is K915624.

When did MODIFIED BIOLOG receive FDA 510(k) clearance?

MODIFIED BIOLOG received FDA 510(k) clearance on 1992-03-27, under 510(k) number K915624.

Who is the listed applicant for MODIFIED BIOLOG?

The FDA 510(k) record lists Micromedical Industries, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED BIOLOG?

The FDA product code for MODIFIED BIOLOG is DRT.

Related Clinical Trials

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Other records listing Micromedical Industries, Ltd. 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.

K013311MODIFICATION TO: POCKETVIEW ECG SOFTWAREK012540BLY-501 ADAPTORK990266MICROMEDICAL 12 LEAD SIMULTANEOUS CABLEK922528CMS SYSTEMK915627PACEVIEW

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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