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FDA 510(k)

PAIN CARE 4200

K-Number: K020988 · 2002-04-04

ApplicantBreg, Inc.
Decision Date2002-04-04
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PAIN CARE 4200 is the device name listed in this FDA 510(k) record. The listed applicant is Breg, Inc.. It received FDA 510(k) clearance on 2002-04-04 under 510(k) number K020988. The device is classified under product code MEB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAIN CARE 4200?

PAIN CARE 4200 is a medical device that received FDA 510(k) clearance on 2002-04-04. The listed applicant is Breg, Inc.. The 510(k) number is K020988.

When did PAIN CARE 4200 receive FDA 510(k) clearance?

PAIN CARE 4200 received FDA 510(k) clearance on 2002-04-04, under 510(k) number K020988.

Who is the listed applicant for PAIN CARE 4200?

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 PAIN CARE 4200?

The FDA product code for PAIN CARE 4200 is MEB.

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 CAREK013928PAIN CARE 3200K003611PAIN CARE MULTI-PORT CATHETER, MODEL 2000LK002073PAIN CARE 3000

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Related Devices (Code: MEB)

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.

K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte. , Ltd.K240624InfuLifeFirst Medical Source, LLCK242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte. , Ltd.K181360ON-Q* Pump with BolusHalyard HealthK151650SMARTez elastomeric infusion pumpEpic Medical Pte. , Ltd.K131247MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEMMfs - Medical Flow Systems, Ltd.

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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