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FDA 510(k)

LIFEDOP MODEL 300ABI

K-Number: K093393 · 2009-12-24

ApplicantSummit Doppler Systems, Inc.
Decision Date2009-12-24
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LIFEDOP MODEL 300ABI 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 2009-12-24 under 510(k) number K093393. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFEDOP MODEL 300ABI?

LIFEDOP MODEL 300ABI is a medical device that received FDA 510(k) clearance on 2009-12-24. The listed applicant is Summit Doppler Systems, Inc.. The 510(k) number is K093393.

When did LIFEDOP MODEL 300ABI receive FDA 510(k) clearance?

LIFEDOP MODEL 300ABI received FDA 510(k) clearance on 2009-12-24, under 510(k) number K093393.

Who is the listed applicant for LIFEDOP MODEL 300ABI?

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 LIFEDOP MODEL 300ABI?

The FDA product code for LIFEDOP MODEL 300ABI is JAF.

Related Clinical Trials

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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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 ABIK101816STN PROBEK090499LIFEDOP MODEL, L350RK063600VISTA AVSK060410ECHOHEART TRANSVAGINAL DOPPLER PROBEK024197LIFEDOP DOPPLER

View all 7 devices →

Related Devices (Code: JAF)

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.

K242487Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc.K110628SIMPLEABINewman MedicalK090009THD SLIDE ONEThd SpaK081429THD SLIDEThd SpaK070815THDG.F. S.R.L.K063600VISTA AVSSummit Doppler Systems, 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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