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FDA 510(k)

ALTHIN MEDICAL AB ALTRACART II

K-Number: K990010 · 1999-04-15

ApplicantAlthin Medical AB
Decision Date1999-04-15
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALTHIN MEDICAL AB ALTRACART II is the device name listed in this FDA 510(k) record. The listed applicant is Althin Medical AB. It received FDA 510(k) clearance on 1999-04-15 under 510(k) number K990010. 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 ALTHIN MEDICAL AB ALTRACART II?

ALTHIN MEDICAL AB ALTRACART II is a medical device that received FDA 510(k) clearance on 1999-04-15. The listed applicant is Althin Medical AB. The 510(k) number is K990010.

When did ALTHIN MEDICAL AB ALTRACART II receive FDA 510(k) clearance?

ALTHIN MEDICAL AB ALTRACART II received FDA 510(k) clearance on 1999-04-15, under 510(k) number K990010.

Who is the listed applicant for ALTHIN MEDICAL AB ALTRACART II?

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

What is the FDA product code for ALTHIN MEDICAL AB ALTRACART II?

The FDA product code for ALTHIN MEDICAL AB ALTRACART II is KPO.

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Other records listing Althin Medical AB 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.

K992573AF-220 HEMODIALYZERK992566AF-150 HEMODIALYZERK992563A-22 HEMODIALYZERK992564AF-180 HEMODIALYZERK992594A-15 HEMODIALYZERK992565A-18 HEMODIALYZER

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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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