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FDA 510(k)

POLAR PUMP, MODEL 500

K-Number: K913729 · 1991-10-18

ApplicantBreg, Inc.
Decision Date1991-10-18
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

POLAR PUMP, MODEL 500 is the device name listed in this FDA 510(k) record. The listed applicant is Breg, Inc.. It received FDA 510(k) clearance on 1991-10-18 under 510(k) number K913729. 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 POLAR PUMP, MODEL 500?

POLAR PUMP, MODEL 500 is a medical device that received FDA 510(k) clearance on 1991-10-18. The listed applicant is Breg, Inc.. The 510(k) number is K913729.

When did POLAR PUMP, MODEL 500 receive FDA 510(k) clearance?

POLAR PUMP, MODEL 500 received FDA 510(k) clearance on 1991-10-18, under 510(k) number K913729.

Who is the listed applicant for POLAR PUMP, MODEL 500?

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

What is the FDA product code for POLAR PUMP, MODEL 500?

The FDA product code for POLAR PUMP, MODEL 500 is ILO.

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.

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Other records listing Breg, 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.

K183702Polar Care WaveK070402MODIFICATION TO POLAR CARE 500K041714E-PAIN CAREK020988PAIN CARE 4200K013928PAIN CARE 3200K003611PAIN CARE MULTI-PORT CATHETER, MODEL 2000L

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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

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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