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FDA 510(k)

FITTING/DIALYZER

K-Number: K760815 · 1976-11-19

ApplicantCobe Laboratories, Inc.
Decision Date1976-11-19
Product CodeFTG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FITTING/DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1976-11-19 under 510(k) number K760815. The device is classified under product code FTG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FITTING/DIALYZER?

FITTING/DIALYZER is a medical device that received FDA 510(k) clearance on 1976-11-19. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K760815.

When did FITTING/DIALYZER receive FDA 510(k) clearance?

FITTING/DIALYZER received FDA 510(k) clearance on 1976-11-19, under 510(k) number K760815.

Who is the listed applicant for FITTING/DIALYZER?

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

What is the FDA product code for FITTING/DIALYZER?

The FDA product code for FITTING/DIALYZER is FTG.

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Other records listing Cobe Laboratories, 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.

K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902631COBE ICU CONVERSION KIT

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Related Devices (Code: FTG)

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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