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FDA 510(k)

ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS

K-Number: K971053 · 1997-06-16

ApplicantInternational Medical Products, Inc.
Decision Date1997-06-16
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Products, Inc.. It received FDA 510(k) clearance on 1997-06-16 under 510(k) number K971053. 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 ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS?

ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS is a medical device that received FDA 510(k) clearance on 1997-06-16. The listed applicant is International Medical Products, Inc.. The 510(k) number is K971053.

When did ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS receive FDA 510(k) clearance?

ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS received FDA 510(k) clearance on 1997-06-16, under 510(k) number K971053.

Who is the listed applicant for ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS?

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

What is the FDA product code for ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS?

The FDA product code for ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS is KPO.

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Other records listing International Medical Products, 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.

K981003ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXESK973253ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATEK920077NIKKISO NK PUMPK923942RHOMBO MEDICAL RHOMBO-FILLK900755DIGITAL CUFF PV GAUGEK864984ROBINJECT

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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

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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