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FDA 510(k)

SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22

K-Number: K863609 · 1987-02-25

ApplicantInternational Medical Products, Inc.
Decision Date1987-02-25
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 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 1987-02-25 under 510(k) number K863609. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22?

SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 is a medical device that received FDA 510(k) clearance on 1987-02-25. The listed applicant is International Medical Products, Inc.. The 510(k) number is K863609.

When did SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 receive FDA 510(k) clearance?

SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 received FDA 510(k) clearance on 1987-02-25, under 510(k) number K863609.

Who is the listed applicant for SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22?

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 SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22?

The FDA product code for SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 is FKP.

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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 DIALYSATEK971053ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSISK920077NIKKISO NK PUMPK923942RHOMBO MEDICAL RHOMBO-FILLK900755DIGITAL CUFF PV GAUGE

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Related Devices (Code: FKP)

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.

K181991NxStage Connected Health SystemNxstage Medical, Inc.K131739NXSTAGE CONNECTED HEALTH SYSTEMNxstage Medical, Inc.K130460NXSTAGE DOSING CALCULATORNxstage Medical, Inc.K040074ONEVIEW INTERFACENxstage Medical, Inc.K021060FRESENIUS ICARE MONITORING SYSTEMFresenius Medical Care North AmericaK003615STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPSEnvironmental Test Systems, Inc.

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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