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FDA 510(k)

IMNI-II

K-Number: K951983 · 1995-06-20

ApplicantCottrell, Ltd.
Decision Date1995-06-20
Product CodeLRJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IMNI-II is the device name listed in this FDA 510(k) record. The listed applicant is Cottrell, Ltd.. It received FDA 510(k) clearance on 1995-06-20 under 510(k) number K951983. The device is classified under product code LRJ. It was reviewed by the HO advisory panel. Product code LRJ falls under the category of Clinical Lab, which includes general clinical laboratory instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMNI-II?

IMNI-II is a medical device that received FDA 510(k) clearance on 1995-06-20. The listed applicant is Cottrell, Ltd.. The 510(k) number is K951983.

When did IMNI-II receive FDA 510(k) clearance?

IMNI-II received FDA 510(k) clearance on 1995-06-20, under 510(k) number K951983.

Who is the listed applicant for IMNI-II?

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

What is the FDA product code for IMNI-II?

The FDA product code for IMNI-II is LRJ. This falls under the Clinical Lab category.

Other records listing Cottrell, Ltd. 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.

K972708ENDO-SPOR PLUS / HYPROCIDEK970726VAPOCIDEK960089PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATORK952241PROTOUCH OVERGLOVEK952234BARRIER ALL FILMK932922PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR

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Related Devices (Code: LRJ)

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.

K992661CONTROL III ELITEMaril Products, Inc.K991509PRO-PORTION CLEANER/DISINFECTANTSultan Chemists, Inc.K984485MICROSTAT 2Chemlink Laboratories, LLCK983947AMERSE 2STERIS CorporationK983869DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACHCaltech Industries, Inc.K983585LOW PH PHENOLIC 256Central Solutions, 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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