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FDA 510(k)

DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3

K-Number: K900242 · 1990-03-22

ApplicantNational Medical Care, Medical Products Div., Inc.
Decision Date1990-03-22
Product CodeKDJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3 is the device name listed in this FDA 510(k) record. The listed applicant is National Medical Care, Medical Products Div., Inc.. It received FDA 510(k) clearance on 1990-03-22 under 510(k) number K900242. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3?

DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3 is a medical device that received FDA 510(k) clearance on 1990-03-22. The listed applicant is National Medical Care, Medical Products Div., Inc.. The 510(k) number is K900242.

When did DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3 receive FDA 510(k) clearance?

DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3 received FDA 510(k) clearance on 1990-03-22, under 510(k) number K900242.

Who is the listed applicant for DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3?

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

What is the FDA product code for DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3?

The FDA product code for DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3 is KDJ.

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Other records listing National Medical Care, Medical Products Div., 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.

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Related Devices (Code: KDJ)

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.

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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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