FDA 510(k)

ACU-HALT

K-Number: K945374 · 1995-08-09

Decision Date1995-08-09

Product CodeLDQ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ACU-HALT is the device name listed in this FDA 510(k) record. The listed applicant is Eva-Health USA, Inc.. It received FDA 510(k) clearance on 1995-08-09 under 510(k) number K945374. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACU-HALT?

ACU-HALT is a medical device that received FDA 510(k) clearance on 1995-08-09. The listed applicant is Eva-Health USA, Inc.. The 510(k) number is K945374.

When did ACU-HALT receive FDA 510(k) clearance?

ACU-HALT received FDA 510(k) clearance on 1995-08-09, under 510(k) number K945374.

Who is the listed applicant for ACU-HALT?

The FDA 510(k) record lists Eva-Health USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACU-HALT?

The FDA product code for ACU-HALT is LDQ.

Related Devices (Code: LDQ)

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.

K993797EC-7701 FLUID WARMING CABINETEnthermics Medical Systems, Inc.K992258HOT SHOT FLUID WARMER IV FLUIDSInfra-Med Technologies, Inc.K981032PIV SYSTEMMedical Solutions, Inc.K973747CONTROLLED TEMPERATURE CABINET SYSTEMSmith K955661ACU-HALTGlederer & Co., Inc.K955776ACU-LABGlederer & Co., 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.