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FDA 510(k)

FLEXWARMER, MODELS KZ-1 AND KZ-2

K-Number: K062644 · 2007-09-11

ApplicantMerlyn Associates, Inc.
Decision Date2007-09-11
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLEXWARMER, MODELS KZ-1 AND KZ-2 is the device name listed in this FDA 510(k) record. The listed applicant is Merlyn Associates, Inc.. It received FDA 510(k) clearance on 2007-09-11 under 510(k) number K062644. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXWARMER, MODELS KZ-1 AND KZ-2?

FLEXWARMER, MODELS KZ-1 AND KZ-2 is a medical device that received FDA 510(k) clearance on 2007-09-11. The listed applicant is Merlyn Associates, Inc.. The 510(k) number is K062644.

When did FLEXWARMER, MODELS KZ-1 AND KZ-2 receive FDA 510(k) clearance?

FLEXWARMER, MODELS KZ-1 AND KZ-2 received FDA 510(k) clearance on 2007-09-11, under 510(k) number K062644.

Who is the listed applicant for FLEXWARMER, MODELS KZ-1 AND KZ-2?

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

What is the FDA product code for FLEXWARMER, MODELS KZ-1 AND KZ-2?

The FDA product code for FLEXWARMER, MODELS KZ-1 AND KZ-2 is LGZ.

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Other records listing Merlyn Associates, 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.

K031794ENDOFLEX TRACHEAL TUBE

Related Devices (Code: LGZ)

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.

K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU MedicalK260988°M Warmer System with °M StationMequ A/SK252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/SK211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.

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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