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FDA 510(k)

PAIN CARE 2000L

K-Number: K002321 · 2000-08-14

ApplicantBreg, Inc.
Decision Date2000-08-14
Product CodeMEB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PAIN CARE 2000L is the device name listed in this FDA 510(k) record. The listed applicant is Breg, Inc.. It received FDA 510(k) clearance on 2000-08-14 under 510(k) number K002321. 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 2000L?

PAIN CARE 2000L is a medical device that received FDA 510(k) clearance on 2000-08-14. The listed applicant is Breg, Inc.. The 510(k) number is K002321.

When did PAIN CARE 2000L receive FDA 510(k) clearance?

PAIN CARE 2000L received FDA 510(k) clearance on 2000-08-14, under 510(k) number K002321.

Who is the listed applicant for PAIN CARE 2000L?

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 2000L?

The FDA product code for PAIN CARE 2000L 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.

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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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