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FDA 510(k)

DIALATORS PC-203 & 202

K-Number: K823330 · 1983-01-26

ApplicantMedigroup
Decision Date1983-01-26
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALATORS PC-203 & 202 is the device name listed in this FDA 510(k) record. The listed applicant is Medigroup. It received FDA 510(k) clearance on 1983-01-26 under 510(k) number K823330. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALATORS PC-203 & 202?

DIALATORS PC-203 & 202 is a medical device that received FDA 510(k) clearance on 1983-01-26. The listed applicant is Medigroup. The 510(k) number is K823330.

When did DIALATORS PC-203 & 202 receive FDA 510(k) clearance?

DIALATORS PC-203 & 202 received FDA 510(k) clearance on 1983-01-26, under 510(k) number K823330.

Who is the listed applicant for DIALATORS PC-203 & 202?

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

What is the FDA product code for DIALATORS PC-203 & 202?

The FDA product code for DIALATORS PC-203 & 202 is FKX.

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Other records listing Medigroup 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.

K823294MEDIGROUP LS-110 LIGHT SOURCEK823295MEDIGROUP 2.2MM NEEDLESCOPE CANNULA&K823297ST-610 NEEDLESCOPE STERILIZATION TRAYK823293MEDIGROUP LG-102 LIGHT GUIDEK823331PC-204 TUNNELORK823390PC 201A LOCKING SLEEVE

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Related Devices (Code: FKX)

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.

K250523Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)Simergent, LLCK243371Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1Byonyks Pvt, Ltd.K220935Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone AppIren-Medical, Ltd.K222318Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLCK212522Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLCK212658CloudCath Peritoneal Dialysis Drain Set Monitoring SystemCloudcath

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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