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FDA 510(k)

LIFEDOP MODEL, L350R

K-Number: K090499 · 2009-03-31

ApplicantSummit Doppler Systems, Inc.
Decision Date2009-03-31
Product CodeMAA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LIFEDOP MODEL, L350R 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 2009-03-31 under 510(k) number K090499. The device is classified under product code MAA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFEDOP MODEL, L350R?

LIFEDOP MODEL, L350R is a medical device that received FDA 510(k) clearance on 2009-03-31. The listed applicant is Summit Doppler Systems, Inc.. The 510(k) number is K090499.

When did LIFEDOP MODEL, L350R receive FDA 510(k) clearance?

LIFEDOP MODEL, L350R received FDA 510(k) clearance on 2009-03-31, under 510(k) number K090499.

Who is the listed applicant for LIFEDOP MODEL, L350R?

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, L350R?

The FDA product code for LIFEDOP MODEL, L350R is MAA.

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 PROBEK093393LIFEDOP MODEL 300ABIK063600VISTA AVSK060410ECHOHEART TRANSVAGINAL DOPPLER PROBEK024197LIFEDOP DOPPLER

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Related Devices (Code: MAA)

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.

K102138ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLEREdan Instruments, Inc.K915138GE SONOCHROMEGE Medical SystemsK905536FETAL DOPPLERToshiba America Medical Systems, In.CK904600L582 TRANSDUCERAcuson Corp.K905456L328 TRANSDUCERAcuson Corp.K904951S5192R TRANSDUCERAcuson Corp.

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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