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FDA 510(k)

NEUROMEDICS ULTRASTIM 650-01

K-Number: K841647 · 1984-07-03

ApplicantIntermedics, Inc.
Decision Date1984-07-03
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NEUROMEDICS ULTRASTIM 650-01 is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1984-07-03 under 510(k) number K841647. 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 NEUROMEDICS ULTRASTIM 650-01?

NEUROMEDICS ULTRASTIM 650-01 is a medical device that received FDA 510(k) clearance on 1984-07-03. The listed applicant is Intermedics, Inc.. The 510(k) number is K841647.

When did NEUROMEDICS ULTRASTIM 650-01 receive FDA 510(k) clearance?

NEUROMEDICS ULTRASTIM 650-01 received FDA 510(k) clearance on 1984-07-03, under 510(k) number K841647.

Who is the listed applicant for NEUROMEDICS ULTRASTIM 650-01?

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

What is the FDA product code for NEUROMEDICS ULTRASTIM 650-01?

The FDA product code for NEUROMEDICS ULTRASTIM 650-01 is IPF.

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Other records listing Intermedics, 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.

K954610MODEL 430-07 ENDOCARDIAL PACING LEADK955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADK962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEADK960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORYK954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

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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

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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