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FDA 510(k)

DOPPLEX SURGICAL PROBES

K-Number: K946300 · 1995-07-26

ApplicantHne Healthcare, Inc.
Decision Date1995-07-26
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DOPPLEX SURGICAL PROBES is the device name listed in this FDA 510(k) record. The listed applicant is Hne Healthcare, Inc.. It received FDA 510(k) clearance on 1995-07-26 under 510(k) number K946300. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOPPLEX SURGICAL PROBES?

DOPPLEX SURGICAL PROBES is a medical device that received FDA 510(k) clearance on 1995-07-26. The listed applicant is Hne Healthcare, Inc.. The 510(k) number is K946300.

When did DOPPLEX SURGICAL PROBES receive FDA 510(k) clearance?

DOPPLEX SURGICAL PROBES received FDA 510(k) clearance on 1995-07-26, under 510(k) number K946300.

Who is the listed applicant for DOPPLEX SURGICAL PROBES?

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

What is the FDA product code for DOPPLEX SURGICAL PROBES?

The FDA product code for DOPPLEX SURGICAL PROBES is ITX.

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Other records listing Hne Healthcare, 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.

K961166FLOWTRON EXCEL PUMP

Related Devices (Code: ITX)

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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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