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FDA 510(k)

SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM

K-Number: K964001 · 1998-04-17

ApplicantMed Institute, Inc.
Decision Date1998-04-17
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Med Institute, Inc.. It received FDA 510(k) clearance on 1998-04-17 under 510(k) number K964001. 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 SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM?

SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-17. The listed applicant is Med Institute, Inc.. The 510(k) number is K964001.

When did SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM receive FDA 510(k) clearance?

SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM received FDA 510(k) clearance on 1998-04-17, under 510(k) number K964001.

Who is the listed applicant for SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM?

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

What is the FDA product code for SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM?

The FDA product code for SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM is ITX.

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Other records listing Med Institute, Inc. as applicant

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Related Devices (Code: ITX)

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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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