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FDA 510(k)

INTERMEDICS/GRASEBY DYNAMICS MS 36

K-Number: K843331 · 1984-11-15

ApplicantIntermedics, Inc.
Decision Date1984-11-15
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INTERMEDICS/GRASEBY DYNAMICS MS 36 is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1984-11-15 under 510(k) number K843331. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERMEDICS/GRASEBY DYNAMICS MS 36?

INTERMEDICS/GRASEBY DYNAMICS MS 36 is a medical device that received FDA 510(k) clearance on 1984-11-15. The listed applicant is Intermedics, Inc.. The 510(k) number is K843331.

When did INTERMEDICS/GRASEBY DYNAMICS MS 36 receive FDA 510(k) clearance?

INTERMEDICS/GRASEBY DYNAMICS MS 36 received FDA 510(k) clearance on 1984-11-15, under 510(k) number K843331.

Who is the listed applicant for INTERMEDICS/GRASEBY DYNAMICS MS 36?

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 INTERMEDICS/GRASEBY DYNAMICS MS 36?

The FDA product code for INTERMEDICS/GRASEBY DYNAMICS MS 36 is FRN.

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Other records listing Intermedics, Inc. as applicant

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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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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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