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FDA 510(k)

MARK VII THERMOREGULATION ASSIST SYSTEM

K-Number: K900355 · 1990-02-15

ApplicantLife Enhancement Technologies, LLC
Decision Date1990-02-15
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MARK VII THERMOREGULATION ASSIST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Life Enhancement Technologies, LLC. It received FDA 510(k) clearance on 1990-02-15 under 510(k) number K900355. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARK VII THERMOREGULATION ASSIST SYSTEM?

MARK VII THERMOREGULATION ASSIST SYSTEM is a medical device that received FDA 510(k) clearance on 1990-02-15. The listed applicant is Life Enhancement Technologies, LLC. The 510(k) number is K900355.

When did MARK VII THERMOREGULATION ASSIST SYSTEM receive FDA 510(k) clearance?

MARK VII THERMOREGULATION ASSIST SYSTEM received FDA 510(k) clearance on 1990-02-15, under 510(k) number K900355.

Who is the listed applicant for MARK VII THERMOREGULATION ASSIST SYSTEM?

The FDA 510(k) record lists Life Enhancement Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MARK VII THERMOREGULATION ASSIST SYSTEM?

The FDA product code for MARK VII THERMOREGULATION ASSIST SYSTEM is ILO.

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Other records listing Life Enhancement Technologies, LLC 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.

K900356THERMOAIRE SPLINT (TM) (TAS)K873200KARLSON OZONE STERILIZER MODEL 100B

Related Devices (Code: ILO)

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.

K213097Armory MotionPain Management Technologies, Inc.K083008COOLSKINElbio Co., Ltd.K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.K072152JUNIPER CLN1 DERMAL COOLING DEVICEJuniper Medical, Inc.K070402MODIFICATION TO POLAR CARE 500Breg, Inc.K040317IVC SYSTEMMark H. Friedman

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.

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