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FDA 510(k)

EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400

K-Number: K002705 · 2001-03-28

ApplicantBaxa Corp.
Decision Date2001-03-28
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 is the device name listed in this FDA 510(k) record. The listed applicant is Baxa Corp.. It received FDA 510(k) clearance on 2001-03-28 under 510(k) number K002705. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400?

EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 is a medical device that received FDA 510(k) clearance on 2001-03-28. The listed applicant is Baxa Corp.. The 510(k) number is K002705.

When did EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 receive FDA 510(k) clearance?

EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 received FDA 510(k) clearance on 2001-03-28, under 510(k) number K002705.

Who is the listed applicant for EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400?

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

What is the FDA product code for EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400?

The FDA product code for EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 is LHI.

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Related Devices (Code: LHI)

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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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