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FDA 510(k)

COBE ACCESSORY INTERFACE MODULE (AIM)

K-Number: K861860 · 1986-07-18

ApplicantCobe Laboratories, Inc.
Decision Date1986-07-18
Product CodeKRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE ACCESSORY INTERFACE MODULE (AIM) 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 1986-07-18 under 510(k) number K861860. The device is classified under product code KRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE ACCESSORY INTERFACE MODULE (AIM)?

COBE ACCESSORY INTERFACE MODULE (AIM) is a medical device that received FDA 510(k) clearance on 1986-07-18. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K861860.

When did COBE ACCESSORY INTERFACE MODULE (AIM) receive FDA 510(k) clearance?

COBE ACCESSORY INTERFACE MODULE (AIM) received FDA 510(k) clearance on 1986-07-18, under 510(k) number K861860.

Who is the listed applicant for COBE ACCESSORY INTERFACE MODULE (AIM)?

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 COBE ACCESSORY INTERFACE MODULE (AIM)?

The FDA product code for COBE ACCESSORY INTERFACE MODULE (AIM) is KRL.

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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: KRL)

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.

K103469STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05Sorin Group Deutschland GmbHK090698CAPIOX BUBBLE TRAP WITH X-COATINGTerumo Cardiovascular SystemsK071231EDAC QUANTIFIERLuna Innovations, Inc.K961364AUTOMATIC TUBING CLAMP SYSTEM (ATC)Rocky Mountain Research, Inc.K961598ELS AUTOMATIC TUBING CLAMP SYSTEMRocky Mountain Research, Inc.K940651SARNS ULTRASONIC AIR SENSOR3M Health Care, Sarns

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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