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FDA 510(k)

AMPCARE ESP THERAPY SYSTEM

K-Number: K131222 · 2013-10-31

ApplicantAmpcare, LLC
Decision Date2013-10-31
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AMPCARE ESP THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ampcare, LLC. It received FDA 510(k) clearance on 2013-10-31 under 510(k) number K131222. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMPCARE ESP THERAPY SYSTEM?

AMPCARE ESP THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-31. The listed applicant is Ampcare, LLC. The 510(k) number is K131222.

When did AMPCARE ESP THERAPY SYSTEM receive FDA 510(k) clearance?

AMPCARE ESP THERAPY SYSTEM received FDA 510(k) clearance on 2013-10-31, under 510(k) number K131222.

Who is the listed applicant for AMPCARE ESP THERAPY SYSTEM?

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

What is the FDA product code for AMPCARE ESP THERAPY SYSTEM?

The FDA product code for AMPCARE ESP THERAPY SYSTEM is IPF.

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 Ampcare, 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.

K121483REUSABLE CUTANEOUS ELECTRODE

Related Devices (Code: IPF)

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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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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