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FDA 510(k)

C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP

K-Number: K821328 · 1982-07-28

ApplicantMedionics International , Ltd.
Decision Date1982-07-28
Product CodeKPF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP 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 1982-07-28 under 510(k) number K821328. The device is classified under product code KPF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP?

C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP is a medical device that received FDA 510(k) clearance on 1982-07-28. The listed applicant is Medionics International , Ltd.. The 510(k) number is K821328.

When did C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP receive FDA 510(k) clearance?

C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP received FDA 510(k) clearance on 1982-07-28, under 510(k) number K821328.

Who is the listed applicant for C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP?

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 #PDC 2000 HCP?

The FDA product code for C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP is KPF.

Related Clinical Trials

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.

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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 SETK842305C.A.P.D. AUTOMATIC HEATER PDH 200K832141MICROSTAR VC1 VOLUMETRIC CYCLERK831766MICROSTAR VCI

Related Devices (Code: KPF)

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.

K061515RENALSOFTBaxter Healthcare CorpK990953RENAL LINKBaxter Healthcare CorpK970989CYBERRENCybernius Medical , Ltd.K955762PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAMFresenius USA, Inc.K913515TOTAL CONTAINMENT DEVICEDencoK875121AMICON EQUALINE FLUID BALANCE SYSTEMAmicon, 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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