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FDA 510(k)

C.A.P.D. AUTOMATIC HEATER PDH 200

K-Number: K842305 · 1984-06-25

ApplicantMedionics International , Ltd.
Decision Date1984-06-25
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

C.A.P.D. AUTOMATIC HEATER PDH 200 is the device name listed in this FDA 510(k) record. The listed applicant is Medionics International , Ltd.. It received FDA 510(k) clearance on 1984-06-25 under 510(k) number K842305. 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 C.A.P.D. AUTOMATIC HEATER PDH 200?

C.A.P.D. AUTOMATIC HEATER PDH 200 is a medical device that received FDA 510(k) clearance on 1984-06-25. The listed applicant is Medionics International , Ltd.. The 510(k) number is K842305.

When did C.A.P.D. AUTOMATIC HEATER PDH 200 receive FDA 510(k) clearance?

C.A.P.D. AUTOMATIC HEATER PDH 200 received FDA 510(k) clearance on 1984-06-25, under 510(k) number K842305.

Who is the listed applicant for C.A.P.D. AUTOMATIC HEATER PDH 200?

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

What is the FDA product code for C.A.P.D. AUTOMATIC HEATER PDH 200?

The FDA product code for C.A.P.D. AUTOMATIC HEATER PDH 200 is FKX.

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Other records listing Medionics International , 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.

K910173SELECTRA AND TUBING SETSK883393CAPD DISPOSABLE Y SYSTEM - DY SETK832141MICROSTAR VC1 VOLUMETRIC CYCLERK831766MICROSTAR VCIK821328C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP

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

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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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