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FDA 510(k)

ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002

K-Number: K964515 · 1996-12-31

Decision Date1996-12-31
Product CodeFNL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 is the device name listed in this FDA 510(k) record. The listed applicant is M.C. Healthcare Products, Inc.. It received FDA 510(k) clearance on 1996-12-31 under 510(k) number K964515. The device is classified under product code FNL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002?

ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 is a medical device that received FDA 510(k) clearance on 1996-12-31. The listed applicant is M.C. Healthcare Products, Inc.. The 510(k) number is K964515.

When did ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 receive FDA 510(k) clearance?

ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 received FDA 510(k) clearance on 1996-12-31, under 510(k) number K964515.

Who is the listed applicant for ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002?

The FDA 510(k) record lists M.C. Healthcare Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002?

The FDA product code for ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001, QD3002 is FNL.

Related Clinical Trials

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.

Other records listing M.C. Healthcare Products, 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.

Related Devices (Code: FNL)

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.

Official Source

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