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FDA 510(k)

BCM DRY PACK BICARBONATE MIXER

K-Number: K873166 · 1987-12-30

ApplicantSpecialty Dialysis Services
Decision Date1987-12-30
Product CodeFIN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BCM DRY PACK BICARBONATE MIXER is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Dialysis Services. It received FDA 510(k) clearance on 1987-12-30 under 510(k) number K873166. The device is classified under product code FIN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BCM DRY PACK BICARBONATE MIXER?

BCM DRY PACK BICARBONATE MIXER is a medical device that received FDA 510(k) clearance on 1987-12-30. The listed applicant is Specialty Dialysis Services. The 510(k) number is K873166.

When did BCM DRY PACK BICARBONATE MIXER receive FDA 510(k) clearance?

BCM DRY PACK BICARBONATE MIXER received FDA 510(k) clearance on 1987-12-30, under 510(k) number K873166.

Who is the listed applicant for BCM DRY PACK BICARBONATE MIXER?

The FDA 510(k) record lists Specialty Dialysis Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BCM DRY PACK BICARBONATE MIXER?

The FDA product code for BCM DRY PACK BICARBONATE MIXER is FIN.

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Related Devices (Code: FIN)

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.

K112427BICARB MIXING AND DISTRIBUTION SYSTEMIsopure, Corp.K093641TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEMTango3, LLCK060333DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEMDialysis Services, Inc.K051031AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSISAmeriwaterK031502USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEMUsfilterK033118BIPRO MODEL SDS-CB200Medical Solutions International

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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