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FDA 510(k)

THE CELL CARE SYSTEM

K-Number: K860537 · 1986-04-17

ApplicantThe Clell Corp.
Decision Date1986-04-17
Product CodeKMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THE CELL CARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is The Clell Corp.. It received FDA 510(k) clearance on 1986-04-17 under 510(k) number K860537. The device is classified under product code KMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE CELL CARE SYSTEM?

THE CELL CARE SYSTEM is a medical device that received FDA 510(k) clearance on 1986-04-17. The listed applicant is The Clell Corp.. The 510(k) number is K860537.

When did THE CELL CARE SYSTEM receive FDA 510(k) clearance?

THE CELL CARE SYSTEM received FDA 510(k) clearance on 1986-04-17, under 510(k) number K860537.

Who is the listed applicant for THE CELL CARE SYSTEM?

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

What is the FDA product code for THE CELL CARE SYSTEM?

The FDA product code for THE CELL CARE SYSTEM is KMI.

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Related Devices (Code: KMI)

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.

K131585INTEL-GE CARE INNOVATIONS QUIETCAREIntel-Ge Care Innovations, LLCK130752DYNASENSE SYSTEMCentauri Medical, Inc.K101109VIVATRAKWireless Medcare, LLCK090138MOBILECARE MONITOR, MODEL 2100Aframe Digital, Inc.K942770ULTIMAT-SENSOR FOR BED OCCUPANCY MONITORUltimate Development Corp.K943481INFORMER PLUSMicro-Tech Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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