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FDA 510(k)

LOW-ACETATE HEMODIALYSIS BATH CONCENTR.

K-Number: K800624 · 1980-07-14

ApplicantTravenol Laboratories, S.A.
Decision Date1980-07-14
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LOW-ACETATE HEMODIALYSIS BATH CONCENTR. is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K800624. 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 LOW-ACETATE HEMODIALYSIS BATH CONCENTR.?

LOW-ACETATE HEMODIALYSIS BATH CONCENTR. is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K800624.

When did LOW-ACETATE HEMODIALYSIS BATH CONCENTR. receive FDA 510(k) clearance?

LOW-ACETATE HEMODIALYSIS BATH CONCENTR. received FDA 510(k) clearance on 1980-07-14, under 510(k) number K800624.

Who is the listed applicant for LOW-ACETATE HEMODIALYSIS BATH CONCENTR.?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOW-ACETATE HEMODIALYSIS BATH CONCENTR.?

The FDA product code for LOW-ACETATE HEMODIALYSIS BATH CONCENTR. is KPO.

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Related Devices (Code: KPO)

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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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