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FDA 510(k)

STN PROBE

K-Number: K101816 · 2010-08-19

ApplicantSummit Doppler Systems, Inc.
Decision Date2010-08-19
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STN PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Summit Doppler Systems, Inc.. It received FDA 510(k) clearance on 2010-08-19 under 510(k) number K101816. 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 STN PROBE?

STN PROBE is a medical device that received FDA 510(k) clearance on 2010-08-19. The listed applicant is Summit Doppler Systems, Inc.. The 510(k) number is K101816.

When did STN PROBE receive FDA 510(k) clearance?

STN PROBE received FDA 510(k) clearance on 2010-08-19, under 510(k) number K101816.

Who is the listed applicant for STN PROBE?

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

What is the FDA product code for STN PROBE?

The FDA product code for STN PROBE is ITX.

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Other records listing Summit Doppler Systems, 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.

K103693VANTAGE ABIK093393LIFEDOP MODEL 300ABIK090499LIFEDOP MODEL, L350RK063600VISTA AVSK060410ECHOHEART TRANSVAGINAL DOPPLER PROBEK024197LIFEDOP DOPPLER

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

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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