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FDA 510(k)

DIALYSATE METER, MODEL D-6

K-Number: K100237 · 2010-04-23

ApplicantMyron L Company
Decision Date2010-04-23
Product CodeFLB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALYSATE METER, MODEL D-6 is the device name listed in this FDA 510(k) record. The listed applicant is Myron L Company. It received FDA 510(k) clearance on 2010-04-23 under 510(k) number K100237. The device is classified under product code FLB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALYSATE METER, MODEL D-6?

DIALYSATE METER, MODEL D-6 is a medical device that received FDA 510(k) clearance on 2010-04-23. The listed applicant is Myron L Company. The 510(k) number is K100237.

When did DIALYSATE METER, MODEL D-6 receive FDA 510(k) clearance?

DIALYSATE METER, MODEL D-6 received FDA 510(k) clearance on 2010-04-23, under 510(k) number K100237.

Who is the listed applicant for DIALYSATE METER, MODEL D-6?

The FDA 510(k) record lists Myron L Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIALYSATE METER, MODEL D-6?

The FDA product code for DIALYSATE METER, MODEL D-6 is FLB.

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Related Devices (Code: FLB)

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.

K92521090DX MULTITEST METER, MODIFICATIONMesa Medical, Inc.K882032MODEL 90DX MULTITEST METERMesa Medical, Inc.K830629COBE RX METERCobe Laboratories, Inc.K821415MODEL 90 BCWestern Laboratories Corp.K770263DIALYSATE METER RS-2100A, CIRCUIT CHANGERenal Systems, Inc.

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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