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FDA 510(k)

HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI

K-Number: K864265 · 1987-03-17

ApplicantDial Medical of Florida, Inc.
Decision Date1987-03-17
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI is the device name listed in this FDA 510(k) record. The listed applicant is Dial Medical of Florida, Inc.. It received FDA 510(k) clearance on 1987-03-17 under 510(k) number K864265. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI?

HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI is a medical device that received FDA 510(k) clearance on 1987-03-17. The listed applicant is Dial Medical of Florida, Inc.. The 510(k) number is K864265.

When did HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI receive FDA 510(k) clearance?

HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI received FDA 510(k) clearance on 1987-03-17, under 510(k) number K864265.

Who is the listed applicant for HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI?

The FDA 510(k) record lists Dial Medical of Florida, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI?

The FDA product code for HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI is KPO.

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Other records listing Dial Medical of Florida, Inc. 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.

K940441DIAL MEDICAL SUPPLY FISTULA NEEDLE SET

Related Devices (Code: KPO)

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.

K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, IncoporatedK253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLCK252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLCK243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLCK240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and DevelopmentK233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLC

Official Source

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