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FDA 510(k)

DYNAMO

K-Number: K944277 · 1994-12-28

ApplicantPride Health Care, Inc.
Decision Date1994-12-28
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

DYNAMO is the device name listed in this FDA 510(k) record. The listed applicant is Pride Health Care, Inc.. It received FDA 510(k) clearance on 1994-12-28 under 510(k) number K944277. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DYNAMO?

DYNAMO is a medical device that received FDA 510(k) clearance on 1994-12-28. The listed applicant is Pride Health Care, Inc.. The 510(k) number is K944277.

When did DYNAMO receive FDA 510(k) clearance?

DYNAMO received FDA 510(k) clearance on 1994-12-28, under 510(k) number K944277.

Who is the listed applicant for DYNAMO?

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

What is the FDA product code for DYNAMO?

The FDA product code for DYNAMO is INI.

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Other records listing Pride Health Care, 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: INI)

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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