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FDA 510(k)

BICARB-O-MATE HEMODIALYSIS SOD. BICARB.

K-Number: K802465 · 1980-11-12

ApplicantRenal Systems, Inc.
Decision Date1980-11-12
Product CodeFKR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BICARB-O-MATE HEMODIALYSIS SOD. BICARB. is the device name listed in this FDA 510(k) record. The listed applicant is Renal Systems, Inc.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802465. The device is classified under product code FKR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BICARB-O-MATE HEMODIALYSIS SOD. BICARB.?

BICARB-O-MATE HEMODIALYSIS SOD. BICARB. is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Renal Systems, Inc.. The 510(k) number is K802465.

When did BICARB-O-MATE HEMODIALYSIS SOD. BICARB. receive FDA 510(k) clearance?

BICARB-O-MATE HEMODIALYSIS SOD. BICARB. received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802465.

Who is the listed applicant for BICARB-O-MATE HEMODIALYSIS SOD. BICARB.?

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

What is the FDA product code for BICARB-O-MATE HEMODIALYSIS SOD. BICARB.?

The FDA product code for BICARB-O-MATE HEMODIALYSIS SOD. BICARB. is FKR.

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Other records listing Renal Systems, 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.

K970648PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)K861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTK854011RENALFO HEMOFILTER CAVHDK844790RENAFLO HEMOCONCENTRATORK843963DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWDK844108RENAL SYSTEMS PERITONEAL ACCESS SYSTEM

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Related Devices (Code: FKR)

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.

K111174NXSTAGE PUREFLOW SLNxstage Medical, Inc.K080919NXSTAGE PUREFLOW SLNxstage Medical, Inc.K060296NXSTAGE DIALYSATE PREPARATION MODULENxstage Medical, Inc.K043436NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269Nxstage Medical, Inc.K850435SARTORIUS AQUASART SM 40035 - DIALYSATE SYSSartorius Filters, Inc.K850756AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTSTravenol Laboratories, S.A.

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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